CTRI/2014/12/005320
Completed
Phase 1
A randomized, open label, cross over study to evaluate the relative bioavailability of GRC 17536 following a single oral administration of three different tablet formulations (45 mg/90 mg/500 mg) with that of two different strengths of granule formulation (90 mg/ 250 mg) in normal healthy male adults.
Glenmark Pharmaceuticals SA0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Glenmark Pharmaceuticals SA
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Normal healthy male volunteers of\>\=18 to \<\= 45 years of age
- •2\. Healthy as determined by medical history, physical examination, chest X\-ray, 12\-lead ECG and laboratory investigations
- •3\. Able and willing to abstain from alcohol and methylxanthine\-containing beverages or food (coffee, tea, cola, chocolate, power drinks)
- •4\. Able and willing to abstain from smoking and the use of other tobacco products
Exclusion Criteria
- •1\. Have abnormal and clinically significant results on the physical examination, medical history, chest X\-ray, 12\-lead ECG and lab investigations;
- •2\. Volunteers with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •3\. History of alcohol abuse (or drug addiction as seen on positive screen on drugs of abuse or positive alcohol breath test.
- •4\. Positive screen on hepatitis\-B surface antigen (HBsAg), antibodies to the Hepatitis C virus (anti\-HCV) or antibodies to the human immunodeficiency virus (HIV) 1/2; or rapid plasma reagin or VDRL.
- •5\. Subjects with known history of liver disease or any abnormal liver function tests at screening
- •6\. Current diagnosis of active epilepsy or any active seizure disorder requiring therapy with antiepileptic drug(s);
- •7\. Subjects who have received any investigational drug in any clinical trial within last 3 months, or who are on extended follow\-up.
Outcomes
Primary Outcomes
Not specified
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