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bioequivalence study on Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg XR tablet

An Open label, balanced, randomized, twotreatment, twoperiod, twosequence, single oral dose, crossover, bioequivalence study on Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg XR tablet of Laboratorios LETI S.A.V., Vs Janumet 100 and 1000 mg XR tablet Sitagliptin Phosphate 100 mg and Metformin Hydrochloride 1000 mg of Merck Sharp and Dohme Corp in healthy adult human subjects under fasting conditions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041021
Enrollment
24
Registered
2022-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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 Phosphate 100 mg and Metformin Hydrochloride 1000 mg tablet: Single dose one time only Control Intervention1: Janumet XR tablet: Single dose one time only

Sponsors

Laboratorios LETI SAV
Lead Sponsor

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 â?? 30 kg/m2 (both inclusive). 5.Normal haemoglobin between 12.5 to 17.5 grams per deciliter (g/dL) for men and 12 to 16 g/dL for female. 6.Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.

Exclusion criteria

Exclusion criteria: 1.Found Positive (+Ve) on Rapid antigen test for COVID-19 during screening. 2.Haemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women. 3.Any medical or surgical conditions, which might significantly interfere with the functioning of the gastrointestinal tract and bloodâ??forming organs. 4.History of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past. 5.History of severe infection or major surgery in the past 6 months. 6.History of Minor surgery or fracture within the past 3 months.

Design outcomes

Primary

MeasureTime frame
Cmax, AUC0-t and AUC0-â??Timepoint: From day 1 to day 12—

Secondary

MeasureTime frame
Tmax , Extrap_obs, λz and t1/2Timepoint: From day 1 to day 12—

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