A Study of BR3003 and co-administration of BR3003B and BR3003C for diabetes mellitus in healthy subjects

Boryung Pharmaceutical Co., Ltd is recruiting patients for the clinical trial of A Study to Evaluate the Pharmacokinetics After Administration of BR3003 and Co-administration of BR3003B and BR3003C.

To perform a comparative evaluation on the pharmacokinetics and the safety after administration of "BR3003" and co-administration of "BR3003B" and "BR3003C" in healthy adults.

A randomized, open-label, single oral dose, two-way crossover study under fasting condition. Target number of subjects: 46 subjects in total.

The researchers plan that April 28, 2022 will be the study start date. The indicative completion of the clinical trial will be expected in June 13, 2022.

Among primary outcome measures are the Primary endpoints(2) and Peak Plasma Concentration(Cmax) of Pioglitazone and Dapagliflozin(Blood samples are collected 22 times for each Period.).

The study will take place at the Clinical Research Center, H PLUS Yangji Hospital, Seoul, Gwanakgu, Korea, Republic of.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05411965 or clinicaltrials.gov/ct2/show/NCT05411965.

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