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Bioequivalence study of Sitagliptin 50 mg and Metformin Hydrochloride 500 mg Extended release tablets in healthy adult human subjects under fed conditions.

An open label, balanced, randomized, two-treatment, two period, two-sequence, single dose, crossover, oral bioequivalence study of Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets by SunGlow Lifescience Private Ltd., with Janumet XR 50 mg/ 500 mg tablets {Sitagliptin and metformin HCl (extended release) tablets 50 mg/500 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fed conditions. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075543
Enrollment
32
Registered
2024-10-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

None listed

Interventions

Intervention1: Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets.: Name of the drug: Sitagliptin 50 mg & Metformin Hydrochloride 500 mg (extended release) Tablets, Route o

Sponsors

Sunglow Lifescience Private Limited
Lead Sponsor
Ms Sunglow Lifescience Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing to provide written informed consent for participation in the study, and an ability to comprehend the nature and purpose of 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 18-55 years (both inclusive) of age. 4. Body mass index in the range of 18.5 – 30.0 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

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 Diabetes mellitus type 1, Diabetic ketoacidosis including history of diabetic coma and precoma, acute or chronic metabolic acidosis, and Severe hepatic dysfunction (lack of experience of administration; in order to provide adequate glycaemic control, such patients should be treated with insulin) 4. Subjects on haemodialysis (lack of experience of administration), Acute and chronic disease which may cause tissue hypoxia (cardiac or respiratory failure, acute and sub-acute myocardial infarction, shock), 5. History of severe infection or major surgery in the past 6 months.

Design outcomes

Primary

MeasureTime frame
To evaluate Pharmacokinetic parameters: Cmax, AUC0-t and AUC0-8Timepoint: From Day 01 to Day 12—

Secondary

MeasureTime frame
To evaluate Pharmacokinetic parameters: Tmax, AUC_%Extrap_obs, ?z and t1/2Timepoint: From Day 01 to Day 12—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Private limited

harish@icbiocro.com09900111997

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026