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Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator

NCT06233201 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2024-01-31

No results posted yet for this study

Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fed condition and at least 7 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Test product

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Manufactured by: Mankind Pharma Limited, India

DRUG

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Reference product

Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Manufactured by: Patheon Puerto Rico, Puerto Rico 00674

Sponsors & Collaborators

  • Bio-innova Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-04
Primary Completion
2024-07-14
Completion
2024-07-28

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233201 on ClinicalTrials.gov