An open label, two stage, single period, single oral dose pharmacokinetic study of Remogliflozin etabonate tablet 100 mg and Remogliflozin etabonate tablet 250 mg of Glenmark pharmaceuticals ltd., India in normal, healthy, adult, human male subjects under fasting and/or fed condition

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 0 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. Healthy adult male subjects aged 18 years to 45 years (both inclusive) at the time of signing the ICF
•2. Not having any significant disease in medical history or clinically significant abnormal findings during screening, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
•3. Able to understand and comply with the study procedures, in the opinion of the principal/Co investigator.
•4. Subjects having eGFR more than 60 mL/min at the time of Screening.

•1. Known hypersensitivity or idiosyncratic reaction to Remogliflozin or any of the excipients or any Gliflozin or related drug.
•2. History or presence of any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
•3. Ingestion of a medicine (CYP-inducers, including herbal medicines) at any time within 14 days before dosing or an unusual diet, for 4 weeks before dosing. In any such cases subject selection will be at the discretion of the Principal Investigator.
•4. Known history of hypoglycaemic episodes in the past one year.
•5. The presence of clinically significant abnormal laboratory values during screening.
•6. History or presence of seizure or psychiatric disorders.
•7. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening

发起方

Glenmark Pharmaceuticals Ltd