drugset / Trial / NCT02620592

Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PKs) of ZYDPLA1 Following Oral Administration in Healthy Volunteers

NCT02620592 ↗

Phase 1 Completed 84 enrolled Zydus Lifesciences Limited
RandomizedParallel-groupQuadruple-blind

Summary

This First in Human (FIH) Phase I study intends to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYDPLA1 in normal healthy adult volunteers.

Timeline

Start
2014-10
Primary completion
2015-10
Completion
2015-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator ZYDPLA1 Unknown 1 mg Oral
Comparator ZYDPLA1 Unknown 5 mg Oral
Comparator ZYDPLA1 Unknown 20 mg Oral
Comparator ZYDPLA1 Unknown 50 mg Oral
Comparator ZYDPLA1 Unknown 100 mg Oral
Comparator ZYDPLA1 Unknown 200 mg Oral

Indications