Study to Evaluate the Effect Of WCK 2349 on the QT/QTc Interval in Health Volunteers
NCT02217930 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2015-10-29
Summary
The study designed to determine the effect induced by WCK 2349 on the QT interval.
The study will be conducted in two parts: 1) to determine the supratherapeutic dose; and 2) to assess the safety of high doses of single-dose administration of WCK 2349 on the QT interval.
Conditions
- Qt Interval, Variation in
Interventions
- DRUG
-
WCK 2349
- DRUG
- DRUG
-
Moxifloxacin
Sponsors & Collaborators
-
Wockhardt
lead INDUSTRY
Principal Investigators
-
Carlos Sanabria, MD · Spaulding Clinical Research Inc.
Study Design
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-08-31
- Primary Completion
- 2014-12-31
- Completion
- 2015-07-31
Countries
- United States
Study Locations
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