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To compare Bioequivalence of test product Sitagliptin 50 mg Metformin Hydrochloride 1000 mg extended release Tablets with reference product in healthy adult human subjects under fasting conditions

An open label balanced randomized two treatment two period two sequence single oral dose crossover bioequivalence study of Sitagliptin 50 mg Metformin Hydrochloride 1000 mg extended release Tablets of SunGlow Lifescience Private Ltd in comparison with Janumet XR 50 mg 1000 mg tablets Sitagliptin and metformin HCl extended release tablets 50 mg 1000 mg of Merck Sharp Dohme Corp in healthy adult human subjects under fasting conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050861
Enrollment
32
Registered
2023-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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 1000 mg (extended release) Tablets: Name of the drug: Sitagliptin 50 mg and Metformin Hydrochloride 1000 mg Route of adminnistration: Oral Fr

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 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 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

Design outcomes

Primary

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

Secondary

MeasureTime frame
To evaluate Pharmacokinetics parameters 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