Bioequivalence study of Sitagliptin 100 mg Metformin Hydrochloride 1000 mg extended release Tablets of SunGlow Lifescience Private Ltd in comparison with Janumet XR 100 mg 1000 mg tablets Sitagliptin and metformin HCl extended release tablets in healthy adult subjects in fed conditio

Not Applicable

• Registration Number: CTRI/2023/06/054073
• Lead Sponsor: SunGlow Lifescience Private 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: ot Yet Recruiting
• 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 â?? 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 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.

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