Trial Outcomes & Findings for Ursodiol 500 mg Tablets Under Fed Conditions (NCT NCT00909753)
NCT ID: NCT00909753
Last Updated: 2024-08-19
Results Overview
Bioequivalence based on Cmax
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
92 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 UrsoForte™ 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
|
46
|
46
|
|
Period: First Intervention
COMPLETED
|
46
|
46
|
|
Period: First Intervention
NOT COMPLETED
|
0
|
0
|
|
Period: Washout of 28 Days
STARTED
|
46
|
46
|
|
Period: Washout of 28 Days
COMPLETED
|
44
|
43
|
|
Period: Washout of 28 Days
NOT COMPLETED
|
2
|
3
|
|
Period: Second Intervention
STARTED
|
44
|
43
|
|
Period: Second Intervention
COMPLETED
|
43
|
43
|
|
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 UrsoForte™ 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: Washout of 28 Days
Protocol Violation
|
2
|
3
|
|
Period: Second Intervention
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Ursodiol 500 mg Tablets Under Fed Conditions
Baseline characteristics by cohort
| Measure |
Ursodiol (Test) First
n=46 Participants
Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
|
Urso Forte™ (Reference) First
n=46 Participants
Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=99 Participants
|
46 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
31 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
46 participants
n=99 Participants
|
46 participants
n=107 Participants
|
92 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
Cmax - Maximum Observed Concentration - for Total Ursodiol
|
6763.805 ng/mL
Standard Deviation 2305.341
|
7461.161 ng/mL
Standard Deviation 2922.024
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on AUC0-72
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
AUC0-72 - Area Under the Concentration-time Curve From Time Zero to 72 Hours Post Dose - for Total Ursodiol
|
84789.776 ng*h/mL
Standard Deviation 33376.080
|
87925.305 ng*h/mL
Standard Deviation 30085.315
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
Cmax for Unconjugated Ursodiol
|
5818.644 ng/mL
Standard Deviation 2145.519
|
6549.897 ng/mL
Standard Deviation 2681.097
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on AUC0-72
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
AUC0-72 for Unconjugated Ursodiol
|
28543.339 ng*h/mL
Standard Deviation 21022.046
|
30951.831 ng*h/mL
Standard Deviation 16492.541
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
Cmax for Total Ursodiol - Baseline Corrected
|
6659.969 ng/mL
Standard Deviation 2304.322
|
7363.215 ng/mL
Standard Deviation 2899.526
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on AUC0-72
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
AUC0-72 for Total Ursodiol - Baseline Corrected
|
77392.805 ng*h/mL
Standard Deviation 25146.096
|
80992.000 ng*h/mL
Standard Deviation 22688.058
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on Cmax
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
Cmax for Unconjugated Ursodiol - Baseline Corrected
|
5794.876 ng/mL
Standard Deviation 2147.270
|
6522.456 ng/mL
Standard Deviation 2679.132
|
PRIMARY outcome
Timeframe: Blood samples collected over 72 hour periodPopulation: Data from all subjects who completed the study was included in the statistical analysis.
Bioequivalence based on AUC0-72
Outcome measures
| Measure |
Ursodiol
n=86 Participants
Ursodiol Tablets, 500 mg dosed in either period
|
Urso Forte™
n=86 Participants
Urso Forte™ Tablets, 500 mg dosed in either period
|
|---|---|---|
|
AUC0-72 for Unconjugated Ursodiol - Baseline Corrected
|
26921.471 ng*h/mL
Standard Deviation 17284.940
|
29177.523 ng*h/mL
Standard Deviation 12620.441
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator is not allowed to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER