Trials / Completed
CompletedNCT04874324
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
Phase-I Double-blind, Randomized, Placebo-controlled Single Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349 Under Fasting Conditions in Adult Healthy Human Volunteers
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Wockhardt · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic data with the data observed in similar studies conducted in India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | WCK 2349 Oral | 1 dose given orally twice daily at 12 hourly interval for five days. |
| OTHER | Placebo Oral | Subjects will receive matching placebo |
Timeline
- Start date
- 2011-03-17
- Primary completion
- 2011-05-04
- Completion
- 2011-06-25
- First posted
- 2021-05-05
- Last updated
- 2022-12-01
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04874324. Inclusion in this directory is not an endorsement.