Bioequivalence study of Metformin prolonged release tablets 1000 mg of Pinnacle Life Science Pvt. Ltd., in healthy human subjects.

Not Applicable

• Registration Number: CTRI/2023/04/051752
• Lead Sponsor: Pinnacle Life Science Pvt. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Able to comprehend the nature and purpose of the study and willing to give written informed consent for participation in the study

2. Willing to be available for the entire study period and to comply with protocol requirements.

3. Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.

4. Body mass index in the range of 18.5 â?? 30 kg/m2 (both inclusive).

Exclusion Criteria

1. Any medical or surgical condition, which might significantly interfere with the functioning of the gastrointestinal tract or bloodâ??forming organs.

2. History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.

3. History of severe infection or major surgery in the past 6 months.

4. History of Minor surgery or fracture within the past 3 months.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax, AUC0-t and AUC0-â??Timepoint: Day 01 to 11

Secondary Outcome Measures

Name	Time	Method
Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: Day 01 to 11