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Ursodiol 500 mg Tablets Under Fed Conditions

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ClinicalTrials.gov Identifier: NCT00909753
Recruitment Status : Completed
First Posted : May 28, 2009
Results First Posted : July 21, 2009
Last Update Posted : August 20, 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: Ursodiol
Drug: Urso Forte™
Enrollment 92

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ursodiol (Test) First Urso Forte™ (Reference) First
Hide Arm/Group Description Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period. Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
Period Title: Period: First Intervention
Started 46 46
Completed 46 46
Not Completed 0 0
Period Title: Period: Washout of 28 Days
Started 46 46
Completed 44 43
Not Completed 2 3
Reason Not Completed
Protocol Violation             2             3
Period Title: Period: Second Intervention
Started 44 43
Completed 43 43
Not Completed 1 0
Reason Not Completed
Protocol Violation             1             0
Arm/Group Title Ursodiol (Test) First Urso Forte™ (Reference) First Total
Hide Arm/Group Description Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period. Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period. Total of all reporting groups
Overall Number of Baseline Participants 46 46 92
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 46 participants 92 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
 100.0%
46
 100.0%
92
 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 46 participants 46 participants 92 participants
Female
13
  28.3%
17
  37.0%
30
  32.6%
Male
33
  71.7%
29
  63.0%
62
  67.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants 46 participants 92 participants
Caucasian 31 33 64
Black 13 11 24
Asian 2 2 4
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 46 participants 46 participants 92 participants
46 46 92
1.Primary Outcome
Title Cmax - Maximum Observed Concentration - for Total Ursodiol
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng/mL
6763.805  (2305.341) 7461.161  (2922.024)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 92.5
Confidence Interval 90%
85.8 to 99.7
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
2.Primary Outcome
Title AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol
Hide Description Bioequivalence based on AUC0-72
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
84789.776  (33376.080) 87925.305  (30085.315)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 95.5
Confidence Interval 90%
92.2 to 98.9
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
3.Primary Outcome
Title Cmax for Unconjugated Ursodiol
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng/mL
5818.644  (2145.519) 6549.897  (2681.097)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 90.4
Confidence Interval 90%
83.1 to 98.3
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
4.Primary Outcome
Title AUC0-72 for Unconjugated Ursodiol
Hide Description Bioequivalence based on AUC0-72
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
28543.339  (21022.046) 30951.831  (16492.541)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 90.5
Confidence Interval 90%
85.5 to 95.9
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
5.Primary Outcome
Title Cmax for Total Ursodiol - Baseline Corrected
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng/mL
6659.969  (2304.322) 7363.215  (2899.526)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 92.2
Confidence Interval 90%
85.5 to 99.5
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
6.Primary Outcome
Title AUC0-72 for Total Ursodiol - Baseline Corrected
Hide Description Bioequivalence based on AUC0-72
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
77392.805  (25146.096) 80992.000  (22688.058)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 95.0
Confidence Interval 90%
91.3 to 98.7
Estimation Comments Bioequivalence is established when 90% Confidence Interval falls within 80-125.
7.Primary Outcome
Title Cmax for Unconjugated Ursodiol - Baseline Corrected
Hide Description Bioequivalence based on Cmax
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng/mL
5794.876  (2147.270) 6522.456  (2679.132)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 90.4
Confidence Interval 90%
83.1 to 98.3
Estimation Comments Bioequivalence is established when 90% COnfidence Interval falls within 80-125.
8.Primary Outcome
Title AUC0-72 for Unconjugated Ursodiol - Baseline Corrected
Hide Description Bioequivalence based on AUC0-72
Time Frame Blood samples collected over 72 hour period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all subjects who completed the study was included in the statistical analysis.
Arm/Group Title Ursodiol Urso Forte™
Hide Arm/Group Description:
Ursodiol Tablets, 500 mg dosed in either period
Urso Forte™ Tablets, 500 mg dosed in either period
Overall Number of Participants Analyzed 86 86
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
26921.471  (17284.940) 29177.523  (12620.441)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ursodiol, Urso Forte™
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Analysis of Variance (ANOVA) will be applied to log-transformed AUC and Cmax parameters.
Method of Estimation Estimation Parameter Geometric Test/Ref Ratio x 100
Estimated Value 90.5
Confidence Interval 90%
85.0 to 96.3
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 allowed 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: NCT00909753     History of Changes
Other Study ID Numbers: 2006-1284
First Submitted: May 26, 2009
First Posted: May 28, 2009
Results First Submitted: June 12, 2009
Results First Posted: July 21, 2009
Last Update Posted: August 20, 2009