Trial Outcomes & Findings for Meloxicam 15 mg Tablets Under Fasting Conditions (NCT NCT00840476)

NCT ID: NCT00840476

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 28 participants
• Primary outcome timeframe: Blood samples collected over 96 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Meloxicam (Test) First Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period	Mobic® (Reference) First Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
First Intervention STARTED	14	14
First Intervention COMPLETED	14	14
First Intervention NOT COMPLETED	0	0
Washout: 14 Days STARTED	14	14
Washout: 14 Days COMPLETED	14	14
Washout: 14 Days NOT COMPLETED	0	0
Second Intervention STARTED	14	14
Second Intervention COMPLETED	14	14
Second Intervention NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Meloxicam 15 mg Tablets Under Fasting Conditions

Baseline characteristics by cohort

Measure	Meloxicam (Test) First n=14 Participants Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period	Mobic® (Reference) First n=14 Participants Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	14 participants n=5 Participants	14 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

Population: 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.

Bioequivalence based on Cmax

Outcome measures

Measure	Meloxicam n=26 Participants Meloxicam 15 mg Tablet (test) dosed in either period	Mobic® n=26 Participants Mobic® 15 mg Tablet (reference) dosed in either period
Cmax - Maximum Observed Concentration	1.50 µg/mL Standard Deviation 0.41	1.51 µg/mL Standard Deviation 0.44

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

Population: 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.

Bioequivalence based on AUC0-inf

Outcome measures

Measure	Meloxicam n=26 Participants Meloxicam 15 mg Tablet (test) dosed in either period	Mobic® n=26 Participants Mobic® 15 mg Tablet (reference) dosed in either period
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)	46.89 µg*h/mL Standard Deviation 17.19	44.82 µg*h/mL Standard Deviation 16.83

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

Population: 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.

Bioequivalence based on AUC0-t

Outcome measures

Measure	Meloxicam n=26 Participants Meloxicam 15 mg Tablet (test) dosed in either period	Mobic® n=26 Participants Mobic® 15 mg Tablet (reference) dosed in either period
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)	43.25 µg*h/mL Standard Deviation 14.27	41.98 µg*h/mL Standard Deviation 15.42

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manager, Biopharmaceutics

Teva Pharmaceuticals USA

Phone: 1-866-384-5525

Email: clinicaltrialqueries@tevausa.com

Results disclosure agreements

• Principal investigator is a sponsor employee Principal Investigator is not permitted to discuss or publish trial results.
• Publication restrictions are in place

Restriction type: OTHER