Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ursodiol · 2 trials · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on AUC0-72
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
| Arm | Type | Description |
|---|---|---|
| Ursodiol (test) First | EXPERIMENTAL | Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg dosed in second period. |
| Urso Forte™ (reference) First | ACTIVE_COMPARATOR | Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period. |
| Name | Type | Description |
|---|---|---|
| Ursodiol | DRUG | Ursodiol Tablets, 500 mg |
| Urso Forte™ | DRUG | Urso Forte™ Tablets, 500 mg |
Inclusion Criteria: * Healthy, non-smoking male and female subjects, 18 years of age or older. * BMI ≥ 19 and ≤ 30. * Negative for: 1. HIV. 2. Hepatitis B surface antigen and Hepatitis C antibody. 3. Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodia...
Ursodiol is a small molecule being developed by Teva Pharmaceutical Industries Limited (TEVA) for use in healthy volunteers. It is currently in Phase 1 clinical development, with studies evaluating the drug under fasting and fed conditions. The drug is not approved and remains investigational.
Ursodiol is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers in Canada.
Ursodiol is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both involving healthy volunteers.
Ursodiol has two completed Phase 1 trials: NCT00909610, a study of Ursodiol 500 mg tablets under fasting conditions with 80 participants, and NCT00909753, a study of Ursodiol 500 mg tablets under fed conditions with 92 participants. Both trials were conducted in Canada.
Ursodiol is not FDA approved. It is an investigational drug currently in Phase 1 clinical development by Teva Pharmaceutical Industries Limited. The completed trials were conducted in healthy volunteers to assess the drug under fasting and fed conditions.