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To compare Bioequivalence study of Sitagliptin 100 mg Metformin Hydrochloride 1000 mg extended release Tablets in healthy adult human subjects under fasting conditions

An open label, balanced, randomized, two-treatment, twoperiod, two-sequence, single oral dose, crossover, 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 100 mg/1,000 mg} of Merck Sharp & Dohme Corp in healthy, adult, human subjects under fasting conditions.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/02/049858
Enrollment
32
Registered
2023-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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 100 mg Metformin Hydrochloride 1000 mg extended release Tablets: Name of the drug: Sitagliptin 100 mg Metformin Hydrochloride 1000 mg Route of administration: Oral Frequenc

Sponsors

SunGlow Lifescience Private Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
To evaluate Pharmacokinetics parameter Cmax, AUC0-t and AUC0-â??Timepoint: From Day 01 to Day 11—

Secondary

MeasureTime frame
To evaluate Pharmacokinetics parameter Tmax , AUC_%Extrap_obs, λz and t1/2Timepoint: From Day 01 to Day 11—

Countries

India

Contacts

Public ContactDr Harish S

ICBio Clinical Research Pvt Ltd

harish@icbiocro.com9900111997

Outcome results

None listed

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