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Trial Outcomes & Findings for Meloxicam 15 mg Tablets Under Non-Fasting Conditions (NCT NCT00840879)

NCT ID: NCT00840879

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

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
13
14
Second Intervention
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
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
Second Intervention
Withdrawal by Subject
1
0

Baseline Characteristics

Meloxicam 15 mg Tablets Under Non-Fasting Conditions

Baseline characteristics by cohort

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
14 Participants
n=5 Participants
14 Participants
n=7 Participants
28 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
6 Participants
n=7 Participants
14 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
8 Participants
n=5 Participants
13 Participants
n=7 Participants
21 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
4 Participants
n=5 Participants
1 Participants
n=7 Participants
5 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 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: One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

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
1.32 µg/mL
Standard Deviation 0.22
1.36 µg/mL
Standard Deviation 0.29

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

Population: One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.

Bioequivalence based on AUC0-inf

Outcome measures

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)
40.50 µg*h/mL
Standard Deviation 15.88
42.38 µg*h/mL
Standard Deviation 17.62

PRIMARY outcome

Timeframe: Blood samples collected over 96 hour period

Population: One subject had a pre-dose concentration greater than 5% of the individuals Cmax value and was excluded from the statistical analysis. Data from all other subjects who completed the study was used in the statistical analysis.

Bioequivalence based on AUC0-t

Outcome measures

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)
37.11 µg*h/mL
Standard Deviation 12.33
38.00 µg*h/mL
Standard Deviation 12.70

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

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