Study to Characterize the Pharmacokinetics of 3 Marketed Products Containing 200 mg Guaifenesin in Healthy Volunteers.
Study Details
Study Description
Brief Summary
Characterize the relative pharmacokinetics (PK) of 3 marketed products containing guaifenesin
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment A: Vicks Cough Syrup for Chesty Coughs Vicks Cough immediate-release (IR) syrup 15 mL (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast |
Drug: Vicks Cough Syrup for Chesty Coughs
Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
|
Experimental: Treatment B: Robitussin Extra Strength Chest Congestion Robitussin Extra Strength Chest Congestion 5 ml (containing 200 mg guaifenesin) every 4 hours x 3 doses with 240 mL of water after an overnight fast |
Drug: Robitussin Extra Strength Chest Congestion
Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
|
Experimental: Treatment C: Organ-I- NR tablet Organ-I- NR 200 mg guaifenesin tablet every 4 hours x 3 doses with 240 mL of water after an overnight fast |
Drug: Organ-I- NR tablet
Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water
|
Outcome Measures
Primary Outcome Measures
- Maximum Observed Plasma Concentration (Cmax) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration.
- Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose.
- Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose).
- Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose [8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours]
Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4. Cav is calculated as AUC(8-12) / dosing interval, 4
- Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration.
- Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose.
- Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel.
- Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Kel is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., 3 or more non-zero plasma concentrations) in the terminal log-linear phase.
- Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method.
- Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was the last measurable concentration and Kel is the apparent first-order terminal elimination rate constant.
- Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours]
AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method.
- Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin [8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours]
AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method.
- Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf).
- Accumulation Index (AI) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hours]
AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4).
- Degree of Fluctuation (DF) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav.
- Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin [0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours]
Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss.
Secondary Outcome Measures
- Number of Participants With Adverse Events (AEs) [Up to day 2 (Period 3)]
Intensity was determined by the Investigator. For symptomatic Adverse Events (AEs) the following definitions were applied. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and/or females between the ages of 19 and 55 years, inclusive.
-
Females of childbearing potential must be using one of the following acceptable birth control methods:
-
Intra-uterine device in place for at least 3 months prior to Day 1 of Period 1 through 30 days beyond study completion;
-
Barrier method (condom or diaphragm) with spermicide for at least 7 days prior to screening through 30 days beyond study completion;
-
Stable hormonal contraceptive (e.g., oral, depo injection, transdermal patch, or vaginal ring) for at least 3 months prior to Day 1 of Period 1 through 30 days beyond completion of study;
Abstinence is not an acceptable form of contraception; however, abstinent female subjects may be admitted to the study if they agree, and have signed a statement to the effect, that upon becoming sexually active, will use a condom with spermicide from screening through 30 days beyond completion of the study.
- Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study or hysterectomy and/or bilateral oophorectomy at least 3 months prior to Day 1 of Period 1) or postmenopausal
2 years prior to Day 1 of Period 1. A follicle stimulating hormone (FSH) concentration >40 miU/mL must be obtained and recorded for any postmenopausal females.
-
Good general health as determined by the Principal Investigator's (PI) review of medical history, physical examination, vital sign measurements, electrocardiogram (ECG), and clinical laboratory measures.
-
Within 15% of ideal body weight (Table of 'Desirable Weights of Adults' Metropolitan Life Insurance Company, 1983).
-
Non-tobacco users, who have not used nicotine or nicotine-containing products for at least 365 days prior to Day 1 of Period 1.
-
Able to read, understand and sign the informed consent after the nature of the study has been explained.
-
Negative urine screen for drugs of abuse and alcohol at screening and each check in.
-
If female, negative finding on serum pregnancy test at screening and each check-in.
Exclusion Criteria:
-
Clinically significant abnormalities detected by medical history, physical examination, vial sign measurements, ECG, or clinical laboratory findings (as determined by the PI/designee) including a hemoglobin value <12 g/dL at screening. If a subject's hemoglobin drops below 11.0 g/dL during the study, the subject may be dropped from the study at the discretion of the PI.
-
Any disease or condition, which could impact absorption, distribution, metabolism, or elimination of the study drugs (as determined by the PI/designee).
-
Alcoholism or medicinal product or drug abuse within the past two years or excessive alcohol consumption (more than 10 units per week) (one unit is defined as 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of spirits (i.e., 'hard' liquor such as gin, whiskey, or vodka, et. al.). The subject is not to experience tolerance, withdrawal, compulsive use, or substance related problems such as medical complications, disruption in social and family relationships, vocational or financial difficulties, or legal problems.
-
Females who are pregnant or nursing.
-
History of sensitivity reaction to guaifenesin.
-
History of or intolerance to lactose.
-
Receipt of an investigational drug within 30 days prior to Day 1 of Period 1.
-
Abnormal diet (for whatever reason) during the 30 days prior to Day 1 of Period 1.
-
Donation of blood or significant loss of blood within 56 days or plasma within 14 days prior to Day 1 of Period 1.
-
Known or suspected use of illicit drugs.
-
The use of any medication (with the exception of hormonal contraceptives for women of childbearing potential) for 14 days or 5 half-lives of the drug (whichever is longer) prior to Day 1 of Period 1, if not approved by Investigator.
-
Test positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV at Screening.
-
Subjects who have participated in previous Reckitt Benckiser studies.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Reckitt Benckiser Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2009-GGE-05
Study Results
Participant Flow
Recruitment Details | This was a single-centre study. |
---|---|
Pre-assignment Detail | A total of 30 subjects entered the study, among them 27 subjects completed the study. |
Arm/Group Title | Treatment Sequence 1 | Treatment Sequence 2 | Treatment Sequence 3 | Treatment Sequence 4 | Treatment Sequence 5 | Treatment Sequence 6 |
---|---|---|---|---|---|---|
Arm/Group Description | Period 1: Treatment A Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 2: Treatment B Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 3: Treatment C Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration | Period 1: Treatment B Robitussin Extra Strength 5ml syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 2: Treatment C Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 3: Treatment A Vicks Cough Syrup 15ml containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration | Period 1: Treatment C Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 2: Treatment A Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 3: Treatment B Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration | Period 1: Treatment A Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 2: Treatment C Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 3: Treatment B Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration | Period 1: Treatment B Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 2: Treatment A Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 3: Treatment C Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration | Period 1: Treatment C Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 2: Treatment B Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Period 3: Treatment A Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration |
Period Title: Period 1 | ||||||
STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
COMPLETED | 5 | 5 | 5 | 5 | 5 | 5 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Period 1 | ||||||
STARTED | 5 | 5 | 5 | 5 | 5 | 5 |
COMPLETED | 4 | 5 | 5 | 4 | 5 | 5 |
NOT COMPLETED | 1 | 0 | 0 | 1 | 0 | 0 |
Period Title: Period 1 | ||||||
STARTED | 4 | 5 | 5 | 4 | 5 | 5 |
COMPLETED | 4 | 5 | 5 | 4 | 5 | 5 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Period Title: Period 1 | ||||||
STARTED | 4 | 5 | 5 | 4 | 5 | 5 |
COMPLETED | 4 | 4 | 5 | 4 | 5 | 5 |
NOT COMPLETED | 0 | 1 | 0 | 0 | 0 | 0 |
Period Title: Period 1 | ||||||
STARTED | 4 | 4 | 5 | 4 | 5 | 5 |
COMPLETED | 4 | 4 | 5 | 4 | 5 | 5 |
NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Treatment A: Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Treatment B: Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast Treatment C: Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast There was a 7 days washout period between each administration Participants randomized to receive either Treatment A or Treatment B or Treatment C in 3 Periods (Period 1, 2, 3) of 6 sequence (ABC, BCA, CAB, ACB, BAC, CBA) |
Overall Participants | 30 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
26.0
(9.54)
|
Sex: Female, Male (Count of Participants) | |
Female |
15
50%
|
Male |
15
50%
|
Race (participants) [Number] | |
Asian |
1
3.3%
|
Black |
1
3.3%
|
Caucasian |
25
83.3%
|
European/Middle Eastern |
1
3.3%
|
Hispanic |
2
6.7%
|
Weight (lb) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [lb] |
157.60
(22.359)
|
Height (in) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [in] |
69.65
(3.246)
|
Frame Size (participants) [Number] | |
Small |
4
13.3%
|
Medium |
23
76.7%
|
Large |
3
10%
|
Elbow Breadth (in) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [in] |
2.661
(0.2140)
|
Outcome Measures
Title | Maximum Observed Plasma Concentration (Cmax) of Guaifenesin |
---|---|
Description | Pharmacokinetic Parameter Cmax is the Maximum observed plasma concentration. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
Pharmacokinetic (PK) analyses were performed on the available data of the subjects that completed at least 1 period. |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng/mL] |
1730
(723)
|
1230
(456)
|
1110
(433)
|
Title | Maximum Measured Plasma Concentration at Steady State (Cmax,ss) of Guaifenesin Following the Third Dose |
---|---|
Description | Pharmacokinetic Parameter Cmax,ss is the Maximum observed plasma concentration following the third dose. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng/mL] |
876
(548)
|
765
(309)
|
796
(317)
|
Title | Observed Plasma Concentration at the End of Dosing Interval at Steady State (Cmin,ss) of Guaifenesin Following the Third Dose |
---|---|
Description | Observed plasma concentration at the end of the dosing interval following the third dose (that is, 4 hours following the third dose). |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng/mL] |
60.3
(33.4)
|
55.1
(28.0)
|
73.6
(59.9)
|
Title | Average Plasma Concentration (Cav) of Guaifenesin Following the Third Dose |
---|---|
Description | Average plasma concentration (Cav) following the third dose, calculated as AUC(8-12) divided by the dosing interval, 4. Cav is calculated as AUC(8-12) / dosing interval, 4 |
Time Frame | 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng/mL] |
357
(168)
|
313
(128)
|
300
(128)
|
Title | Time to Maximum Observed Plasma Concentration (Tmax) of Guaifenesin |
---|---|
Description | Pharmacokinetic Parameter Tmax is the time of the maximum observed plasma concentration. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [hr] |
2.66
(2.32)
|
2.94
(2.00)
|
3.91
(2.29)
|
Title | Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of Guaifenesin Following the Third Dose |
---|---|
Description | Pharmacokinetic Parameter Tmax, ss is the time of the maximum observed plasma concentration following the third dose. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [hr] |
8.70
(0.333)
|
8.67
(0.244)
|
9.02
(0.374)
|
Title | Apparent First-order Terminal Elimination Half-life (T1/2) of Guaifenesin |
---|---|
Description | T1/2 is the apparent first-order terminal elimination half-life, calculated as ln(2)/Kel. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 27 | 28 |
Mean (Standard Deviation) [hr] |
0.961
(0.0973)
|
1.04
(0.138)
|
0.941
(0.130)
|
Title | Apparent First-order Terminal Elimination Rate Constant (Kel) of Guaifenesin |
---|---|
Description | Kel is the apparent first-order terminal elimination rate constant calculated from a semi-log plot of the plasma concentration versus time curve. The parameter was calculated by linear least-squares (LS) regression analysis using the maximum number of points (e.g., 3 or more non-zero plasma concentrations) in the terminal log-linear phase. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 27 | 28 |
Mean (Standard Deviation) [1/hr] |
0.729
(0.0780)
|
0.677
(0.0898)
|
0.750
(0.0987)
|
Title | Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Concentration [AUC(0-t)] of Guaifenesin |
---|---|
Description | AUC(0-t) is the area under the plasma concentration versus time curve from time 0 to the time of the last measurable concentration, as calculated by the linear trapezoidal method. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng*hr/mL] |
5588.99
(2329.08)
|
4369.98
(1708.25)
|
4223.74
(1798.98)
|
Title | Area Under Plasma Concentration Versus Time Curve From Time 0 to Infinity [AUC(0-inf)] of Guaifenesin |
---|---|
Description | AUC(0-inf) is the area under the plasma concentration versus time curve from time 0 to infinity, calculated as AUC(0-t) + Ct/Kel, where Ct was the last measurable concentration and Kel is the apparent first-order terminal elimination rate constant. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 27 | 28 |
Mean (Standard Deviation) [ng*hr/mL] |
5596.33
(2330.20)
|
4427.06
(1721.91)
|
4232.61
(1801.69)
|
Title | Area Under Plasma Concentration Versus Time Curve From 0 to 4 Hours [AUC(0-4)] of Guaifenesin |
---|---|
Description | AUC(0-4) is the area under the plasma concentration versus time curve from time 0 to 4 hours post dose (relative to first dose), as calculated by the linear trapezoidal method. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3 and 4 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng*hr/mL] |
2013.16
(785.006)
|
1490.15
(579.667)
|
1414.18
(617.126)
|
Title | Area Under Plasma Concentration Versus Time Curve From Time 8 to 12 Hours [AUC(8-12)] of Guaifenesin |
---|---|
Description | AUC(8-12) is the area under the plasma concentration versus time curve from time 8 to 12 hours postdose (relative to first dose), as calculated by the linear trapezoidal method. |
Time Frame | 8, 8.5, 8.75, 9, 9.5, 10, 11 and 12 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [ng*hr/mL] |
1427.70
(672.821)
|
1253.09
(511.519)
|
1198.55
(511.210)
|
Title | Area Under Plasma Concentration Curve Ratio (AUCR) of Guaifenesin |
---|---|
Description | Pharmacokinetic Parameter AUCR is the Ratio of AUC(0-t) to AUC(0-inf). AUCR = AUC(0-t) / AUC(0-inf). |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 27 | 28 |
Mean (Standard Deviation) [Ratio] |
0.9986
(0.000592)
|
0.9982
(0.001138)
|
0.9978
(0.001724)
|
Title | Accumulation Index (AI) of Guaifenesin |
---|---|
Description | AI is the accumulation index, calculated as AUC(8-12) / AUC(0-4). |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4 hours and 8, 8.5, 8.75, 9, 9.5, 10, 11, 12 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [Ratio] |
0.7056
(0.1299)
|
0.8420
(0.1180)
|
0.8592
(0.1304)
|
Title | Degree of Fluctuation (DF) of Guaifenesin |
---|---|
Description | DF is the Degree of Fluctuation Index, calculated as (Cmax,ss - Cmin,ss) / Cav. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [Percent fluctuation in concentration] |
2.220
(0.5508)
|
2.312
(0.5221)
|
2.463
(0.6758)
|
Title | Peak Plasma Concentrations at Steady State (Swing) of Guaifenesin |
---|---|
Description | Pharmacokinetic Parameter Swing is Calculated as (Cmax,ss - Cmin,ss) / Cmin,ss. |
Time Frame | 0 (Pre-dose), 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 4.75, 5, 5.5, 6, 7, 8, 8.5, 8.75, 9, 9.5, 10, 11, 12, 14 and 16 hours |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 26 | 28 | 28 |
Mean (Standard Deviation) [Percentage] |
16.19
(10.03)
|
15.62
(8.908)
|
0.750
(0.0987)
|
Title | Number of Participants With Adverse Events (AEs) |
---|---|
Description | Intensity was determined by the Investigator. For symptomatic Adverse Events (AEs) the following definitions were applied. Mild = AE did not limit usual activities; subject may have experienced slight discomfort. Moderate = AE resulted in some limitation of usual activities; subject may have experienced significant discomfort. Severe = AE resulted in an inability to carry out usual activities; subject may have experienced intolerable discomfort/pain. Relationship to Investigational Medicinal Products (IMP) Unlikely = Slight, but remote, chance that AE was caused by IMP. Possible = Reasonable suspicion that the AE was caused by IMP. Probable = Most likely that AE was caused by IMP. |
Time Frame | Up to day 2 (Period 3) |
Outcome Measure Data
Analysis Population Description |
---|
PK analyses |
Arm/Group Title | Treatment A | Treatment B | Treatment C |
---|---|---|---|
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast |
Measure Participants | 29 | 28 | 28 |
TEAE by severity: Mild |
5
16.7%
|
1
NaN
|
4
NaN
|
TEAE by severity: Moderate |
2
6.7%
|
0
NaN
|
1
NaN
|
TEAE by severity: Severe |
0
0%
|
0
NaN
|
0
NaN
|
Relationship to IMP - Unlikely |
5
16.7%
|
1
NaN
|
2
NaN
|
Relationship to IMP - Possible |
1
3.3%
|
0
NaN
|
2
NaN
|
Relationship to IMP - Probable |
0
0%
|
0
NaN
|
0
NaN
|
Adverse Events
Time Frame | Up to day 2 (Period 3) | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Treatment A | Treatment B | Treatment C | |||
Arm/Group Description | Vicks Cough Syrup 15 mL containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Robitussin Extra Strength 5mL syrup containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | Organ-I NR Tablet containing 200 mg guaifenesin every 4 hour for 3 doses by mouth after an overnight fast | |||
All Cause Mortality |
||||||
Treatment A | Treatment B | Treatment C | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/29 (0%) | 0/28 (0%) | 0/28 (0%) | |||
Serious Adverse Events |
||||||
Treatment A | Treatment B | Treatment C | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/29 (0%) | 0/28 (0%) | 0/28 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Treatment A | Treatment B | Treatment C | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 5/29 (17.2%) | 1/28 (3.6%) | 4/28 (14.3%) | |||
Gastrointestinal disorders | ||||||
Abdominal pain upper | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Diarrhoea | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Vomiting | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 |
General disorders | ||||||
Feeling hot | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Vessel puncture site haematoma | 1/29 (3.4%) | 2 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||||
Myalgia | 0/29 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 |
Nervous system disorders | ||||||
Dizziness | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Headache | 2/29 (6.9%) | 2 | 1/28 (3.6%) | 1 | 2/28 (7.1%) | 3 |
Reproductive system and breast disorders | ||||||
Dysmenorrhoea | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Vulvovaginal pruritus | 1/29 (3.4%) | 1 | 0/28 (0%) | 0 | 0/28 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||
Oropharyngeal pain | 0/29 (0%) | 0 | 0/28 (0%) | 0 | 1/28 (3.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Clinical Research Director, Clinical Research |
---|---|
Organization | Reckitt Benckiser, Inc |
Phone | |
clinicalrequests@rb.com |
- 2009-GGE-05