drugset / Trial / NCT01472809

A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral ZYGK1 in Healthy Volunteers

NCT01472809 ↗

Phase 1 Suspended 96 enrolled Zydus Lifesciences Limited
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine (1) whether ZYGK1 is safe and well tolerated, (2) the pharmacokinetics (what body does to ZYGK1) and (3) pharmacodynamics (what drugs does to the body) in the healthy and diabetic subject.

Timeline

Start
2011-12
Primary completion
2012-12
Completion
—

Outcome

Outcome not reported

Stopped: “Not achieved the objective till 4 mg single dose”

Drugs

EvaluationDrugModalityDoseRoute
Subject ZYGK1 Unknown 0.125 mg Oral
Subject ZYGK1 Unknown 0.25 mg Oral
Subject ZYGK1 Unknown 0.5 mg Oral
Subject ZYGK1 Unknown 1 mg Oral
Subject ZYGK1 Unknown 2 mg Oral

Indications