A Clinical Study to Evaluate the Safety,Tolerability and PK of ZYT1, Following Oral Administration in Healthy Volunteers
Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
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.