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Meloxicam 15 mg Tablets Under Non-Fasting Conditions

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ClinicalTrials.gov Identifier: NCT00840879
Recruitment Status : Completed
First Posted : February 10, 2009
Results First Posted : August 4, 2009
Last Update Posted : September 11, 2009
Sponsor:
Information provided by:
Teva Pharmaceuticals USA

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: Meloxicam 15 mg Tablets
Drug: Mobic® 15 mg Tablets
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Meloxicam (Test) First Mobic® (Reference) First
Hide 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: Washout: 14 Days
Started 14 14
Completed 14 14
Not Completed 0 0
Period Title: Second Intervention
Started 14 14
Completed 13 14
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
Arm/Group Title Meloxicam (Test) First Mobic® (Reference) First Total
Hide 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 Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
14
 100.0%
14
 100.0%
28
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
8
  57.1%
6
  42.9%
14
  50.0%
Male
6
  42.9%
8
  57.1%
14
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Caucasian 8 13 21
Black 4 1 5
Asian 2 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 14 participants 14 participants 28 participants
14 14 28
1.Primary Outcome
Title Cmax - Maximum Observed Concentration
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 96 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meloxicam Mobic®
Hide Arm/Group Description:
Meloxicam 15 mg Tablet (test) dosed in either period
Mobic® 15 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: µg/mL
1.32  (0.22) 1.36  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam, Mobic®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 98.15
Confidence Interval 90%
90.96 to 105.90
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)
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 96 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meloxicam Mobic®
Hide Arm/Group Description:
Meloxicam 15 mg Tablet (test) dosed in either period
Mobic® 15 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: µg*h/mL
40.50  (15.88) 42.38  (17.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam, Mobic®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 96.34
Confidence Interval 90%
91.82 to 101.07
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)
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 96 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Meloxicam Mobic®
Hide Arm/Group Description:
Meloxicam 15 mg Tablet (test) dosed in either period
Mobic® 15 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: µg*h/mL
37.11  (12.33) 38.00  (12.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Meloxicam, Mobic®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of variance (ANOVA) was performed on pharmacokinetic parameters of AUC0-t, AUCinf and Cmax.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 97.76
Confidence Interval 90%
93.31 to 102.42
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Principal Investigator is not permitted to discuss or publish trial results.
Results Point of Contact
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
ClinicalTrials.gov Identifier: NCT00840879     History of Changes
Other Study ID Numbers: 2825
First Submitted: February 6, 2009
First Posted: February 10, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 4, 2009
Last Update Posted: September 11, 2009