Meloxicam 15 mg Tablets Under Fasting Conditions

• Sponsor: Teva Pharmaceuticals USA (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00840476
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

The objective of this study is to compare the rate and extent of absorption of meloxicam from a test formulation Meloxicam 15 mg Tablets versus the reference Mobic® 15 mg Tablets under fasting conditions.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Meloxicam 15 mg Tablets; Drug: Mobic® 15 mg Tablets	Phase 1

Detailed Description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Official Title: A Two-way Crossover, Open-label, Single-dose, Fasting, Bioequivalence Study of Meloxicam 15 mg Tablets Versus Mobic® 15 mg Tablets in Normal Healthy Non-Smoking Male and Female Subjects
• Study Start Date: Feb 1, 2004
• Actual Primary Completion Date: Feb 1, 2004
• Actual Study Completion Date: Feb 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meloxicam Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period	Drug: Meloxicam 15 mg Tablets; 1 x 15 mg, single-dose fasting
Active Comparator: Mobic® Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period	Drug: Mobic® 15 mg Tablets; 1 x 15 mg, single-dose fasting

Outcome Measures

Primary Outcome Measures

1. Cmax - Maximum Observed Concentration [Blood samples collected over 96 hour period]

   Bioequivalence based on Cmax

2. AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) [Blood samples collected over 96 hour period]

   Bioequivalence based on AUC0-inf

3. AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) [Blood samples collected over 96 hour period]

   Bioequivalence based on AUC0-t

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Non-smoking male or female with a minimum age of 18 years (i.e. non-smoker or non tobacco user for at least 90 days prior to pre-study medical).

• Body mass Index (BMI = weight/height²) greater than or equal to 18.5 kg/m² and less than or equal to 29.9 kg/m².

• Availability of subject for the entire study period and willingness to adhere to protocol requirements, as evidenced by a signed Informed Consent Form.

• Normal findings in the physical examination, 12-lead ECG and vital signs (blood pressure between 100-140/60-90 mmHg, heart rate between 50-99 beats/min, temperature between 35.8ºC and 37.5ºC).

• Negative for drugs of abuse, nicotine, alcohol, hepatitis B-surface antigen, hepatitis C and HIV, and for female subjects, pregnancy (serum ß-CG).

• No clinical laboratory values outside of the acceptable range as defined by BCR, unless the Principal Investigator decides they are not clinically significant.

• Female subjects who are surgically sterile for at least six months or post-menopausal for at least one year, or who will avoid pregnancy prior to the study, during the study and up until one month after the end of the study.

Exclusion Criteria:

• Known history of hypersensitivity to meloxicam (for example Mobic®), or related drugs such as any other non-steroidal anti-inflammatory drugs (NSAID) such as acetylsalicyclic acid (e.g. Excedrin®, Aspirin®), ibuprofen (e.g. Motrin®), celecoxib (e.g. Celebrex®), Feldene®, Indocin®, Naprosyn®, Vioxx®, Toradol®, Clinoril®, Tolectin®, or Lodine®.

• Known history or presence of cardiac, pulmonary, gastrointestinal, endocrine, musculoskeletal, neurological, hematological, or liver disease, unless judged not clinically significant by the Principal Investigator, or medical designate.

• Any history or presence of peptic ulcer disease, gastrointestinal bleeding, or kidney disease.

• Known history or presence of food allergies, or any condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.

• Any clinically significant illness during the last four weeks prior to entry into this study.

• Presence of any significant physical or organ abnormality.

• Any subject with history of drug abuse.

• Any psychiatric or psychological disease (including depression) unless deemed not clinically significant by the Principal Investigator, or medical designate.

• Use of any prescription medication within 14 days preceding entry into this study.

• Use of over-the-counter (OTC) medication within seven days preceding entry into this study (except for spermicidal/barrier contraceptive products).

• Female subjects: use of oral contraceptives or contraceptive implants (such as Norplant®) within 30 days prior to drug administration or a depot injection of progestogen drug (e.g. Depo-Provera®) within one year prior to drug administration.

• Female subjects: presence of pregnancy or lactation.

• Female subjects at risk of becoming pregnant must consent to using two medically acceptable methods of contraception throughout the entire study, including the washout period and for one month after the completion of the study. Medically acceptable barrier methods of contraception that may be used by the subject and/or partner include diaphragm with spermicide, IUD, condom with foam, and vaginal spermicidal suppository. Complete abstinence can be used alone as a method of contraception.

• Any subject who has had blood drawn within 56 days preceding this study, taken during the conduct of any clinical study at a facility other than BCR or within the lockout period specified by a previous study conducted at BCR.

• Participation in a clinical trial with an investigational drug within 30 days preceding this study.

• Any subject who has donated blood within 56 days preceding this study.

• Any subject who has participated as a plasma donor in a plasmapheresis program within seven days preceding this study.

• Any subject with a recent (less than one year) history of alcohol abuse.

• Significant or recent history of asthma (after 12 years of age), or familial history of asthma or aspirin-sensitive asthma, sever bronchospasm, nasal polyps or chronic sinusitis.

• Intolerance to venipuncture.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Biovail Contract Research	Toronto	Ontario	Canada	M1L4S4

Sponsors and Collaborators

• Teva Pharmaceuticals USA

Investigators

• Principal Investigator: Paul Y. Tam, M.D., Biovail Contract Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00840476
• Other Study ID Numbers: 2824
• First Posted: Feb 10, 2009
• Last Update Posted: Sep 15, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Bioequivalence; Healthy Subjects
• Additional relevant MeSH terms: Meloxicam

Study Results

Participant Flow

Arm/Group Title	Meloxicam (Test) First	Mobic® (Reference) First
Arm/Group Description	Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period	Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
Period Title: First Intervention
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	14	14
COMPLETED	14	14
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Meloxicam (Test) First	Mobic® (Reference) First	Total
Arm/Group Description	Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period	Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period	Total of all reporting groups
Overall Participants	14	14	28
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 92.9%	14 100%	27 96.4%
>=65 years	1 7.1%	0 0%	1 3.6%
Sex: Female, Male (Count of Participants)
Female	8 57.1%	4 28.6%	12 42.9%
Male	6 42.9%	10 71.4%	16 57.1%
Race/Ethnicity, Customized (Number) [Number]
Caucasian	9 64.3%	9 64.3%	18 64.3%
Black	3 21.4%	4 28.6%	7 25%
Asian	2 14.3%	1 7.1%	3 10.7%
Region of Enrollment (participants) [Number]
Canada	14 100%	14 100%	28 100%

Outcome Measures

1. Primary Outcome

Title	Cmax - Maximum Observed Concentration
Description	Bioequivalence based on Cmax
Time Frame	Blood samples collected over 96 hour period

Outcome Measure Data

Analysis Population Description

The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.

Arm/Group Title	Meloxicam	Mobic®
Arm/Group Description	Meloxicam 15 mg Tablet (test) dosed in either period	Mobic® 15 mg Tablet (reference) dosed in either period
Measure Participants	26	26
Mean (Standard Deviation) [µg/mL]	1.50 (0.41)	1.51 (0.44)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Meloxicam, Mobic®
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Test/Ref Ratio of LS Means x 100
	Estimated Value	100.26
	Confidence Interval	() 90%; 93.12 to 107.95
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established when 90% Confidence Interval falls within 80-125.

2. Primary Outcome

Title	AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
Description	Bioequivalence based on AUC0-inf
Time Frame	Blood samples collected over 96 hour period

Outcome Measure Data

Analysis Population Description

The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.

Arm/Group Title	Meloxicam	Mobic®
Arm/Group Description	Meloxicam 15 mg Tablet (test) dosed in either period	Mobic® 15 mg Tablet (reference) dosed in either period
Measure Participants	26	26
Mean (Standard Deviation) [µg*h/mL]	46.89 (17.19)	44.82 (16.83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Meloxicam, Mobic®
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Test/Ref Ratio of LS Means x 100
	Estimated Value	105.14
	Confidence Interval	() 90%; 100.27 to 110.25
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established when 90% Confidence Interval falls within 80-125.

3. Primary Outcome

Title	AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
Description	Bioequivalence based on AUC0-t
Time Frame	Blood samples collected over 96 hour period

Outcome Measure Data

Analysis Population Description

The data from two completed subjects was not included in the statistical analysis due to pre-dose concentrations greater than 5% of the individuals Cmax value.

Arm/Group Title	Meloxicam	Mobic®
Arm/Group Description	Meloxicam 15 mg Tablet (test) dosed in either period	Mobic® 15 mg Tablet (reference) dosed in either period
Measure Participants	26	26
Mean (Standard Deviation) [µg*h/mL]	43.25 (14.27)	41.98 (15.42)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Meloxicam, Mobic®
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Test/Ref Ratio of LS Means x 100
	Estimated Value	104.33
	Confidence Interval	() 90%; 99.16 to 109.76
	Parameter Dispersion	Type: Value:
	Estimation Comments	Bioequivalence is established when 90% Confidence Interval falls within 80-125.

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Principal Investigator is not permitted to discuss or publish trial results.