Pure Global

Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets - Trial NCT06248801

Access comprehensive clinical trial information for NCT06248801 through Pure Global AI's free database. This Phase 1 trial is sponsored by Bio-innova Co., Ltd and is currently Not yet recruiting. The study focuses on Healthy Subjects. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT06248801
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06248801
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets
A Bioequivalence Study of Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets in Healthy Thai Adult Volunteers Under Fed Condition.

Study Focus

Healthy Subjects

Vildagliptin and Metformin-Test product

Interventional

drug

Sponsor & Location

Bio-innova Co., Ltd

Timeline & Enrollment

Phase 1

Sep 05, 2024

Oct 15, 2024

48 participants

Primary Outcome

Area under the plasma concentration-time curve from time zero to the last measurable concentration (AUC 0-t),Maximal measured plasma concentration (Cmax)

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.

ICD-10 Classifications

Occupational health examination
Seeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmful
Routine child health examination
Examination and observation for other reasons

Data Source

ClinicalTrials.gov

NCT06248801

Non-Device Trial