Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Effect of Food
Interventions
DRUG

Oral WCK2349

The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.

DRUG

IV WCK771

The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.

Trial Locations (1)

78744

PPD Phase I unit, 7551 Metro Center Drive, Suite 200, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Wockhardt

INDUSTRY

NCT01875939 - Phase I, Open Label,Crossover Food-Effect and Absolute Bioavailability Study of WCK2349 and WCK771 in Healthy Adult Human Volunteers | Biotech Hunter | Biotech Hunter