Trials / Completed
CompletedNCT03926962
The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
Double-Blind, Randomized, Placebo-Controlled Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Ascending Doses And The Effect Of Food On Oral WCK 4873 In Healthy Adult Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Wockhardt · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part and a 2-way crossover food effect (FE) part. Each subject will participate in only one cohort during the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WCK 4873 | 100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets) |
| DRUG | Placebo Oral Tablet | Visually matching placebo |
Timeline
- Start date
- 2013-03-14
- Primary completion
- 2013-06-25
- Completion
- 2013-07-13
- First posted
- 2019-04-25
- Last updated
- 2019-04-25
Source: ClinicalTrials.gov record NCT03926962. Inclusion in this directory is not an endorsement.