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An Open-Label, Randomized, Single-Dose, 2-Treatment, 2-Sequence, Crossover, Exploratory Pharmacokinetic and Bioavailability Study of 2 Capsule Formulations of TR-701 (Torezolid Phosphate) in Normal Healthy Adults
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 2 different TR-701 oral formulations (free acid phosphate powder in capsule and di-sodium phosphate salt formulated capsule) after single doses in normal healthy adult subjects and to assess the relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule.
Details
| Lead sponsor | Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2009-02 |
| Completion | 2009-03 |
Conditions
- Healthy
Interventions
- TR-701 di-sodium phosphate salt
- TR-701 free acid phosphate
Primary outcomes
- To evaluate the pharmacokinetics and relative bioavailability of TR-701 free acid phosphate powder in capsule formulation compared to di-sodium phosphate salt formulated capsule after single doses in normal healthy adult subjects — 4 days
Countries
United States