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An Open-label, Randomized, Fed, Single-dose, 2-sequence, 2-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of "BR3006" and Co-administration of "BR3006A", "BR3006B" and "BR3006C" in Healthy Adult Volunteers
This was an open-label, randomized, fed, single-dose, 2-sequence, 2- period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
A total of 40 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fed.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
Yes
H Plus Yangji Hospital
Seoul, Gwanak-gu, South Korea
Start Date
July 5, 2025
Primary Completion Date
July 5, 2026
Completion Date
July 5, 2026
Last Updated
July 24, 2025
40
ESTIMATED participants
Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
DRUG
Dapagliflozin 10 mg
DRUG
Pioglitazone 30 mg
DRUG
Metformin HCl 1000 mg
DRUG
Lead Sponsor
Boryung Pharmaceutical Co., Ltd
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06060392