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Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets

NCT06248801 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-08

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 fasting condition and at least 14 days washout period between the doses.

Conditions

  • Healthy Subjects

Interventions

DRUG

Vildagliptin and Metformin-Test product

Vildagliptin and Metformin tablets 50/1000 mg manufactured by Mylan Laboratories Limited, India

DRUG

Vildagliptin and Metformin-Reference product

Vildagliptin and Metformin tablets 50/1000 mg manufactured by NOVARTIS PHARMA PRODUKTIONS GmbH, Germany.

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
2024-09-05
Primary Completion
2024-10-01
Completion
2024-10-15

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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 NCT06248801 on ClinicalTrials.gov