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The Bioequivalence Study of Fixed-dose Combination of Vildagliptin and Metformin HCI 50/1000 mg FCT Under Fed Conditions

NCT06244407 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-07

No results posted yet for this study

Summary

To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fed conditions

Conditions

  • Healthy Volunteer

Interventions

DRUG

Vildagliptin and Metformin Hydrochloride 50mg 1000 mg Film-coated Tablets

Vildagliptin and Metformin Hydrochloride 50/1000 mg Film-coated Tablets

Sponsors & Collaborators

  • International Bio service

    lead NETWORK

Principal Investigators

  • Uthai Suvanakoot, Ph.D.Pharm · International Bio service

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2024-05-25
Completion
2024-06-02

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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 NCT06244407 on ClinicalTrials.gov