A study to assess the remogliflozin levels and safety after administration of Remogliflozin etabonate tablets in healthy volunteers.

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/10/010043

Enrollment

Registered

2017-10-09

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 100 mg and 250 mg: Single oral dose of Remogliflozin Etabonate Tablets 100 mg or 250 mg will be administered to each subject in single period (5 Cohorts)

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, 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
PK parameters (Cmax, AUC0-t and AUC0-â??) assessment after single dose of Remogliflozin etabonate tablets under fasting and/or fed conditionTimepoint: 24 hours	—

Secondary

Measure	Time frame
Safety parameters including adverse events, clinical laboratory tests, electrocardiogram, and vital signs assessments during the study durationTimepoint: 3 months	—

Countries

India

Contacts

Public ContactVinu C A

Glenmark Pharmaceuticals Ltd.

Girish.Gudi@glenmarkpharma.com912267720000

Outcome results