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

Recruiting

• Conditions: Fasting condition

• Registration Number: CTRI/2023/02/049858
• Lead Sponsor: SunGlow Lifescience Private Ltd

Brief Summary

STUDY TITLE:

An open label, balanced, randomized, two-treatment, two-period, 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.



OBJECTIVES:

*Primary objective:*

To compare the rate and extent of absorption of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets of SunGlow Lifescience Private Ltd., with that of 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 condition.

*Secondary objective:*

To monitor the safety and tolerability of the study subjects after administration of Sitagliptin 100 mg & Metformin Hydrochloride 1000 mg (extended release) Tablets in healthy, adult, human subjects under fasting condition



Number of subjects: Thirty two (32)

Duration of clinical study : 11 days

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-20
• Last Update Posted: 2023-02-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• 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.
• Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
• Body mass index in the range of 18 – 30 kg/m2 (both inclusive).
• 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 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.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameter Cmax, AUC0-t and AUC0-∞	From Day 01 to Day 11

Secondary Outcome Measures

Name	Time	Method
To evaluate Pharmacokinetics parameter Tmax , AUC_%Extrap_obs, λz and t1/2	From Day 01 to Day 11

Trial Locations

Locations (1)

ICBio Clinical Research Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

ICBio Clinical Research Pvt Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Priya R

Principal investigator

9900111997

pi.mail@icbiocro.com