Bioequivalence study of Metformin prolonged release tablets 1000 mg in comparison with Glucophage®1000 mg XR tablets (Metformin Hydrochloride prolonged release tablets) of in healthy, adult, human subjects under fed conditions

Not Applicable

• Registration Number: CTRI/2023/04/051403
• 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 30 kg m2

both inclusive

5 Healthy volunteers who are clinically non anemic will be included as per the discretion of PI CI Physician

Exclusion Criteria

1 Any medical or surgical condition which might significantly interfere with the functioning of the gastrointestinal tract or blood 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

5 Significant history or current evidence of malignancy or chronic infectious cardiovascular renal hepatic ophthalmic pulmonary neurological metabolic endocrine hematological gastrointestinal immunological or psychiatric diseases or organ dysfunction

Study & Design

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