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

NCT02620592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2015-12-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ZYDPLA1 tablet

The oral dose of ZYDPLA1 tablet administered with 240 ± 10 mL of water at ambient temperature.

DRUG

Placebo tablet

The oral dose of placebo tablet administered with 240 ± 10 mL of water at ambient temperature.

Sponsors & Collaborators

Principal Investigators

  • Rajendrakumar H Jani, Ph.D., · Zydus Lifesciences Limited

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620592 on ClinicalTrials.gov