Trial Outcomes & Findings for Ursodiol Tablets 500 mg Under Fasting Conditions (NCT NCT00909610)

NCT ID: NCT00909610

Last Updated: 2024-08-19

Results Overview

Bioequivalence based on Cmax

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 80 participants
• Primary outcome timeframe: Blood samples collected over 72 hour period
• Results posted on: 2024-08-19

Participant Flow

Participant milestones

Measure	Ursodiol (Test) First Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.	Urso Forte™ (Reference) First Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
Period: First Intervention STARTED	40	40
Period: First Intervention COMPLETED	40	39
Period: First Intervention NOT COMPLETED	0	1
Period: Washout of 28 Days STARTED	40	39
Period: Washout of 28 Days COMPLETED	37	33
Period: Washout of 28 Days NOT COMPLETED	3	6
Period: Second Intervention STARTED	37	33
Period: Second Intervention COMPLETED	36	33
Period: Second Intervention NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Ursodiol (Test) First Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.	Urso Forte™ (Reference) First Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
Period: First Intervention Adverse Event	0	1
Period: Washout of 28 Days Withdrawal by Subject	3	6
Period: Second Intervention Adverse Event	1	0

Baseline Characteristics

Ursodiol Tablets 500 mg Under Fasting Conditions

Baseline characteristics by cohort

Measure	Ursodiol n=40 Participants Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.	Urso Forte™ n=40 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.	Total n=80 Participants Total of all reporting groups
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	24 Participants n=7 Participants	44 Participants n=5 Participants
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	40 Participants n=5 Participants	40 Participants n=7 Participants	80 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized Black	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Canada	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
Cmax - Maximum Observed Concentration - for Total Ursodiol	4946.800 ng/mL Standard Deviation 1919.778	5026.891 ng/mL Standard Deviation 2274.811

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-72

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours - for Total Ursodiol	76949.818 ng*h/mL Standard Deviation 29582.802	73342.048 ng*h/mL Standard Deviation 32482.856

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
Cmax for Baseline Corrected Total Ursodiol	4864.646 ng/mL Standard Deviation 1910.294	4954.583 ng/mL Standard Deviation 2255.564

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-72

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
AUC0-72 for Baseline Corrected Total Ursodiol	71039.735 ng*h/mL Standard Deviation 25782.013	68003.665 ng*h/mL Standard Deviation 27591.922

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
Cmax for Unconjugated Ursodiol	4412.700 ng/mL Standard Deviation 1714.737	4475.406 ng/mL Standard Deviation 2066.537

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-72

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
AUC0-72 for Unconjugated Ursodiol	26739.080 ng*h/mL Standard Deviation 15149.751	24303.192 ng*h/mL Standard Deviation 11676.848

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on Cmax

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
Cmax for Unconjugated Ursodiol - Baseline Corrected	4384.711 ng/mL Standard Deviation 1716.444	4456.451 ng/mL Standard Deviation 2066.590

PRIMARY outcome

Timeframe: Blood samples collected over 72 hour period

Population: Data from all subjects who completed the study was included in the statistical analysis.

Bioequivalence based on AUC0-72

Outcome measures

Measure	Ursodiol n=69 Participants Ursodiol Tablets, 500 mg (test) dosed in either period	Urso Forte™ n=69 Participants Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
AUC0-72 for Unconjugated Ursodiol - Baseline Corrected	24795.871 ng*h/mL Standard Deviation 14561.991	22948.483 ng*h/mL Standard Deviation 10755.947

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