Trials / Unknown
UnknownNCT06266988
A Bioequivalence Study of Sacubitril/Valsartan Film-coated Tablets Under Fasting Conditions
A Bioequivalence Study of Two Formulations of Sacubitril/Valsartan 97 mg/103 mg Film-coated Tablets in Healthy Thai Subjects Under Fasting Conditions
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
Summary
Primary objective is to is to evaluate the bioequivalence of two formulations
Detailed description
The objectives of this study is to evaluate the bioequivalence of two formulations of sacubitril/valsartan 97 mg/103 mg film coated tablets, Entresto® (Reference) and Sacubitril and Valsartan Tablets 97mg/103mg (Test), after a single oral dose administration in healthy Thai subjects under fasting conditions and secondarily to examine the pharmacokinetics and safety of sacubitril, sacubitrilat and valsartan in healthy Thai subjects under fasting conditions
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sacubitril and Valsartan Tablets 97mg/103mg | Each Tablet contains 97 mg of Sacubitril and 103 mg of Valsartan |
| DRUG | Entresto (Sacubitril and Valsartan Tablets 97mg/103mg) | Each Tablet contains 97.2 mg sacubitril and 102.8 mg valsartan as sodium salt complex |
Timeline
- Start date
- 2024-03-01
- Primary completion
- 2024-04-01
- Completion
- 2024-08-01
- First posted
- 2024-02-20
- Last updated
- 2024-02-20
Source: ClinicalTrials.gov record NCT06266988. Inclusion in this directory is not an endorsement.