A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
Study Details
Study Description
Brief Summary
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods. Participants will receive one preparation of cephalexin in each period. At least 7 hours will pass between the study periods. The study is expected to last about 2 days for each participant, not including screening or follow-up.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Cephalexin (Test) Cephalexin manufactured in Italy by Facta administered once orally in one of two study periods. |
Drug: Cephalexin
Administered Orally
Other Names:
|
Experimental: Cephalexin (Reference) Cephalexin manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. |
Drug: Cephalexin
Administered Orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose [Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period]
Secondary Outcome Measures
- Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum [Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period]
- Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin [Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participation will be voluntary.
-
The body mass index of participants should be between 18-27.
-
Participants should have a good health status.
-
Limits of variation allowed within normal values at screening will be: blood pressure (seated) up to 139 millimeters of mercury (mm Hg), for systolic, and up to 89 mm Hg for diastolic; heart rate between 60 and 100 beats per minute, and respiratory rate between 14 and 20 breaths per minute.
-
Hepatitis B and C and human immunodeficiency virus (HIV) negative.
-
Drug abuse or alcohol detection test approximately 12 hours before administering the study medication.
-
Serum pregnancy test (beta human chorionic gonadotropin) at screening and urine pregnancy test approximately 12 hours before administering the study medication.
Exclusion Criteria:
-
Participants with any clinically significant abnormality in their vital sign constants recorded at screening.
-
Sponsor´s and/or site employees.
-
Abnormal 12 lead electrocardiogram (ECG) that in the opinion of the investigator places the participant at an unacceptable risk for study participation, Bazett corrected QR interval (QTcB) > 470 millisecond (msec) for women and > 450 msec for men.
-
Participants with history of cardiovascular, renal, hepatic, muscular, metabolic, gastrointestinal diseases, including constipation, neurological, endocrine, hematopoietic diseases, or any type of anemia, asthma, mental disease, or other organic abnormalities.
-
Participants with a creatinine clearance < 80 mL/min based on the Cockcroft-Gault equation.
-
Participants requiring any medication during the study, apart from the medication which is being studied.
-
Participants with history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer.
-
Participants who have been exposed to medications known as hepatic enzyme inducers or inhibitors or who have been taking potentially toxic medications within the 30 days prior.
-
Participants who have received any medication, including vitamins (with or without medical prescription) or herbal-based remedies 30 days (or 7 half-lives) prior to the beginning of the study.
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Participants who have been hospitalized for any condition within six months to the beginning of the study.
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Participants who have received investigational drugs within the 60 days prior to the study.
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Participants allergic to any medication, food, or substance.
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Participants who require therapy with nephrotoxic drugs.
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Participants who have donated 450 mL of blood or more within the 60 days prior to the beginning of the study.
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Participants with history of drug and alcohol abuse.
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Participants with special diet requirement for any cause.
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Participants with positive to pregnancy test or are breastfeeding.
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Participants on hormonal treatment by any route.
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Participants who have not been recorded in the page of the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Mexico City | Mexico | 14610 |
Sponsors and Collaborators
- Eli Lilly and Company
- Investigacion Farmacologica y Biofarmaceutica, S.A. de C.V.
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15315
- A3Q-ME-AFBR
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Cephalexin Dosing Sequence AB | Cephalexin Dosing Sequence BA |
---|---|---|
Arm/Group Description | Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion).There was an interval of 1 day between doses. | Each participant was administered Cephalexin B formulation (Treatment B, Test - 1 occasion) and Cephalexin A formulation (Treatment A, Reference - 1 occasion).There was an interval of 1 day between doses. |
Period Title: Period 1 (7 Days) | ||
STARTED | 14 | 14 |
COMPLETED | 14 | 14 |
NOT COMPLETED | 0 | 0 |
Period Title: Period 1 (7 Days) | ||
STARTED | 14 | 14 |
COMPLETED | 14 | 14 |
NOT COMPLETED | 0 | 0 |
Period Title: Period 1 (7 Days) | ||
STARTED | 14 | 14 |
COMPLETED | 14 | 13 |
NOT COMPLETED | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Overall Study |
---|---|
Arm/Group Description | Each participant was administered Cephalexin A formulation (Treatment A, Reference - 1 occasion) and Cephalexin B formulation (Treatment B, Test - 1 occasion) |
Overall Participants | 28 |
Age (Years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [Years] |
28.3
(5.11)
|
Sex: Female, Male (Count of Participants) | |
Female |
10
35.7%
|
Male |
18
64.3%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
28
100%
|
Not Hispanic or Latino |
0
0%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (participants) [Number] | |
Mexico |
28
100%
|
Outcome Measures
Title | Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Cephalexin Following a Single Dose |
---|---|
Description | |
Time Frame | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period |
Outcome Measure Data
Analysis Population Description |
---|
All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data. |
Arm/Group Title | Cephalexin (Test) | Cephalexin (Reference) |
---|---|---|
Arm/Group Description | Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods. | Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. |
Measure Participants | 26 | 26 |
Geometric Mean (Geometric Coefficient of Variation) [hour*microgram per milliliter (h*µg/mL)] |
36.256
(15.513)
|
38.198
(14.385)
|
Title | Pharmacokinetics: Time to Reach Maximum Observed Concentration (Tmax) of Cephalexin Following a Single Dose Maximum |
---|---|
Description | |
Time Frame | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period |
Outcome Measure Data
Analysis Population Description |
---|
All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data. |
Arm/Group Title | Cephalexin (Test) | Cephalexin (Reference) |
---|---|---|
Arm/Group Description | Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods. | Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. |
Measure Participants | 26 | 26 |
Median (Standard Deviation) [Hours] |
0.750
(0.197)
|
0.750
(0.154)
|
Title | Pharmacokinetics: Maximum Concentration (Cmax) of Cephalexin |
---|---|
Description | |
Time Frame | Pre-dose, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 hours in each period |
Outcome Measure Data
Analysis Population Description |
---|
All participants who had at least one study treatment and had evaluable pharmacokinetic (PK) data. |
Arm/Group Title | Cephalexin (Test) | Cephalexin (Reference) |
---|---|---|
Arm/Group Description | Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods. | Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. |
Measure Participants | 26 | 26 |
Geometric Mean (Geometric Coefficient of Variation) [Microgram per milliliter(μg/mL)] |
24.608
(20.712)
|
26.410
(22.140)
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Cephalexin (Test) | Cephalexin (Reference) | ||
Arm/Group Description | Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods. | Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods. | ||
All Cause Mortality |
||||
Cephalexin (Test) | Cephalexin (Reference) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Cephalexin (Test) | Cephalexin (Reference) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/28 (0%) | 0/28 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Cephalexin (Test) | Cephalexin (Reference) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/28 (0%) | 0/28 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Chief Medical Officer |
---|---|
Organization | Eli Lilly and Company |
Phone | 800-545-5979 |
- 15315
- A3Q-ME-AFBR