A study to assess the safety and effect of remogliflozin etabonate tablet in healthy volunteers

An open label, single treatment, single period, single oral dose pharmacokinetic study of remogliflozin etabonate tablet 250 mg of Glenmark Pharmaceuticals Ltd., India in normal, healthy, adult, human male subjects under fasting condition

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/06/008887

Enrollment

Registered

2017-06-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Remogliflozin Etabonate Tablets 250 mg: Single oral dose of one tablet containing 250 mg of Remogliflozin Etabonate will be administered to each subject in a single period. Control Inte

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety parameters including adverse events, clinical, laboratory, electrocardiogram, and vital signs assessments during the study duration.Timepoint: 6 days	—

Countries

India

Contacts

Public ContactVikas Joshi

Glenmark Pharmaceuticals Limited

Nikhil.Sawant@glenmarkpharma.com912261383131

Outcome results