Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Moexipril/hydrochlorothiazide 15 · 2 trials · 1 indication
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Moexipril HCl/hydrochlorothiazide 15/25 mg tablets | DRUG | 1 x 15/25 mg |
| UNIRETIC® 15/25 mg tablets | DRUG | 1 x 15/25 mg |
Inclusion Criteria: * All subjects selected for this study will be non-smokers at least 18 years of age. * Subjects will have a BMI index (body mass index) of 30 or less. Exclusion Criteria: * Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious...
Moexipril/hydrochlorothiazide 15 is a fixed-dose combination product containing moexipril hydrochloride and hydrochlorothiazide in 15/25 mg tablets. It is a small molecule medicine developed by Teva Pharmaceutical Industries Limited. The listed development stage is Phase 1, and the studied trials enrolled healthy adult volunteers rather than patients with a disclosed disease.
Moexipril/hydrochlorothiazide 15 contains moexipril, which targets angiotensin-converting enzyme (ACE) and acts as an ACE inhibitor. Hydrochlorothiazide is the second component of the fixed-dose combination. The ACE target is the molecular target associated with the moexipril portion of the tablet.
Teva Pharmaceutical Industries Limited is the developer of moexipril/hydrochlorothiazide 15. Teva trades on the Nasdaq under the ticker TEVA. The company is listed as the sponsor of the clinical studies conducted for this 15/25 mg tablet formulation.
Moexipril/hydrochlorothiazide 15 is in Phase 1 development. Both of its recorded trials are Phase 1 studies, and both are completed, with no active trials currently listed. The program has not been described as approved, so it remains an investigational product in clinical development.
Two completed Phase 1 trials are recorded for moexipril/hydrochlorothiazide 15: NCT00835042, which studied the 15/25 mg tablets under fasting conditions, and NCT00834067, which studied the same tablets under non-fasting conditions. Each trial enrolled 60 healthy volunteers in the United States, for a total enrollment of 120 participants.