A study to assess the safety and effect of remogliflozin etabonate tablet in healthy volunteers
- Registration Number
- CTRI/2017/06/008887
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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, medical history, physical examination, laboratory evaluations, 12- lead ECG and X-ray chest (P/A view) recordings.
3.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 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.History or presence of seizure or psychiatric disorders.
4.Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PK parameters (Cmax, AUC0-t and AUC0-â??) will be assessed after single dose of remogliflozin etabonate 250 mg tablets under fasting condition in healthy adult male subjects.Timepoint: 24 hours
- Secondary Outcome Measures
Name Time Method Safety parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments during the study duration.Timepoint: 6 days