drugset / Trial / NCT01875939

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

NCT01875939 ↗

Phase 1 Completed 12 enrolled Wockhardt
RandomizedCrossoverOpen-label

Summary

This study is aimed to ascertain the effect of food on pharmacokinetics of WCK 2349 and determine the absolute bioavailability of WCK 2349 1000 mg (oral, QD dose) with respect to WCK 771 800 mg (intravenous, QD dose). This study would ascertain/confirm the therapeutically equivalent oral and IV doses of WCK 2349 and WCK 771 respectively, and provide guidance in case of switch over therapy (WCK 771, IV to WCK 2349, oral) in future clinical trials in patients.

Timeline

Start
2013-06
Primary completion
2013-06
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject WCK 2349 Unknown 1000 mg Oral
Subject WCK 771 Unknown 800 mg Intravenous

Indications

No indication recorded.