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NCT06233045Not yet recruiting

Dapagliflozin Tablet 10 mg Relative to Forxiga® Tablets 10 mg

A Bioequivalence Study of a Randomized, Open-label, Single Dose, Two-way Crossover Design With Two-period, Two-treatment and Two-sequence of Dapagliflozin Tablet 10 mg Relative to Forxiga® in Healthy Thai Volunteers Under Fasting Condition
Bio-innova Co., LtdPhase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Healthy Subjects
Drug/Device/Intervention
Dapagliflozin-Test product
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Bio-innova Co., Ltd
Timeline & enrollment
Phase
Phase 1
Start date
Jul 23, 2024
End date
Sep 08, 2024
Enrollment
30 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 5 days washout period between the doses.

ICD-10 classifications
Occupational health examinationSeeking and accepting physical, nutritional and chemical interventions known to be hazardous and harmfulRoutine child health examinationExamination and observation for other reasons
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06233045
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06233045 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 30 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.