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A Clinical Study to Evaluate the Safety,Tolerability and PK of ZYT1, Following Oral Administration in Healthy Volunteers

NCT01543269 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-11-24

No results posted yet for this study

Summary

This is a clinical study to evaluate the safety, tolerability and pharmacokinetics of ZYT1, following oral administrations in healthy volunteers.

The study shall be divided into four plans as given below:

1. Plan I: Single dose escalation trial
2. Plan II: Multiple dose escalation trial
3. Plan III: Food effect trial.
4. Plan IV: Gender Effect trial.

The safety and tolerability shall be evaluated using physical examinations, Standard laboratory tests (hematology, biochemistry and urine examination), electrocardiogram (ECG) and thyroid scanning. Spontaneously reported and solicited adverse events will also be used for safety parameters.

Conditions

Interventions

DRUG

ZYT1

Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature.

DRUG

Placebo tablets

Oral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature.

Sponsors & Collaborators

Principal Investigators

  • Rajendrakumar H Jani, PhD(Medical) · Zydus Research Centre, Cadila Healthcare Limited,Moriya, Ahmedabad-382213, Gujrat, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • India

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 NCT01543269 on ClinicalTrials.gov