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A Food Effect Study of 60mg ER Torsemide
This study will evaluate the effects of a high-fat meal (food effect) on the bioavailability and pharmacokinetics of 60mg ER Torsemide tablet after single dose oral administration in healthy volunteers. The study will be conducted as a two-sequence to period crossover study to compare 60mg ER Torsemide ER bioavailability under fed and fasting conditions. 60mg ER torsemide is a new strength and dosage form.
Details
| Lead sponsor | Sarfez Pharmaceuticals, Inc. |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 28 |
| Start date | Tue Oct 17 2017 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Sat Mar 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Food-drug Interaction
Interventions
- Fed- 60mg ER Torsemide
- Fasting- 60mg ER Torsemide
Countries
India