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Trial record 4 of 9 for:    Glucovance

Glyburide/Metformin 5 mg/500 mg Film-Coated Tablets, Fasting

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ClinicalTrials.gov Identifier: NCT00836472
Recruitment Status : Completed
First Posted : February 4, 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: Glyburide/Metformin 5 mg/500 mg Tablets
Drug: Glucovance® 5 mg/500 mg Tablets
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Glyburide Metformin (Test) First Glucovance® (Reference) First
Hide Arm/Group Description Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
Period Title: First Intervention
Started 30 30
Completed 30 30
Not Completed 0 0
Period Title: Washout
Started 30 30
Completed 28 27
Not Completed 2 3
Reason Not Completed
Adverse Event             1             2
Withdrawal by Subject             1             1
Period Title: Second Intervention
Started 28 27
Completed 28 27
Not Completed 0 0
Arm/Group Title Glyburide Metformin (Test) First Glucovance® (Reference) First Total
Hide Arm/Group Description Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
26
  86.7%
29
  96.7%
55
  91.7%
>=65 years
4
  13.3%
1
   3.3%
5
   8.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
8
  26.7%
11
  36.7%
19
  31.7%
Male
22
  73.3%
19
  63.3%
41
  68.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Caucasian 28 23 51
Black 1 6 7
Asian 1 0 1
American Hispanic 0 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Cmax (Maximum Observed Concentration) - Glyburide
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Glyburide Metformin Glucovance®
Hide Arm/Group Description:
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
Glucovance® 5/500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng/mL
106.46  (34.86) 116.53  (52.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glyburide Metformin, Glucovance®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 96.41
Confidence Interval 90%
88.43 to 105.10
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)] - Glyburide
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Glyburide Metformin Glucovance®
Hide Arm/Group Description:
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
Glucovance® 5/500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
805.92  (28813) 806.89  (256.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glyburide Metformin, Glucovance®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 98.78
Confidence Interval 90%
95.14 to 102.57
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)] - Glyburide
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Glyburide Metformin Glucovance®
Hide Arm/Group Description:
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
Glucovance® 5/500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
773.84  (276.56) 781.35  (255.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glyburide Metformin, Glucovance®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 98.52
Confidence Interval 90%
94.44 to 102.78
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
4.Primary Outcome
Title Cmax (Maximum Observed Concentration) - Metformin
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Glyburide Metformin Glucovance®
Hide Arm/Group Description:
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
Glucovance® 5/500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng/mL
840.23  (249.06) 889.45  (253.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glyburide Metformin, Glucovance®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 94.08
Confidence Interval 90%
89.60 to 98.77
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
5.Primary Outcome
Title AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Metformin
Hide Description Bioequivalence based on AUC0-inf
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Glyburide Metformin Glucovance®
Hide Arm/Group Description:
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
Glucovance® 5/500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5915.32  (1663.04) 6047.23  (1353.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glyburide Metformin, Glucovance®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 96.33
Confidence Interval 90%
92.60 to 100.21
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
6.Primary Outcome
Title AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Metformin
Hide Description Bioequivalence based on AUC0-t
Time Frame Blood samples collected over 36 hour period
Hide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study were included in the statistical analysis.
Arm/Group Title Glyburide Metformin Glucovance®
Hide Arm/Group Description:
Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
Glucovance® 5/500 mg Tablet (reference) dosed in either period
Overall Number of Participants Analyzed 55 55
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5798.89  (1660.66) 5942.99  (1343.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Glyburide Metformin, Glucovance®
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Using GLM procedures in SAS, analysis of variance (ANOVA)was performed on log-transformed AUC0-t, AUC0-inf and Cmax at the significance level of 0.05.
Method of Estimation Estimation Parameter Test/Ref Ratio of LS Means x 100
Estimated Value 96.01
Confidence Interval 90%
92.18 to 100.00
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
Layout table for Results Point of Contact information
Name/Title: Manager, Biopharmaceutics
Organization: Teva Pharmaceuticals USA
Phone: 1-866-384-5525
EMail: clinicaltrialqueries@tevausa.com
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00836472     History of Changes
Other Study ID Numbers: 02349
First Submitted: February 3, 2009
First Posted: February 4, 2009
Results First Submitted: June 30, 2009
Results First Posted: August 4, 2009
Last Update Posted: September 11, 2009