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 个研究点目标入组 60 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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.

发起方

Glenmark Pharmaceuticals SA