A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)

Boryung

Status and phase: Enrolling; Phase 1

Conditions: Diabete Mellitus

Treatments: Drug: Metformin HCl 1000 mg; Drug: Dapagliflozin 10 mg; Drug: Pioglitazone 30 mg; Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07083401

BR-DPMC-CT-105

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged over 19 at the time of consent
• Those who are eligible to participate in the clinical trial at the discretion of the principal investigator (or a subinvestigator) through laboratory tests such as hematology tests, blood chemistry tests, serology tests, urine tests, and electrocardiogram (ECG) tests that were planned/performed with specification to the investigational product.
• Those who provided written consent after receiving sufficient explanations and fully understood the objective and details of this clinical trial, the characteristics of the investigational product, and the expected adverse events.

Exclusion criteria

• Those who have administered investigational products within 6 months from the first dose administration date in another clinical trial (including bioequivalent studies) (The end of study date is based on the last dose administration date.)
• Those who have undergone gastrointestinal surgeries or have gastrointestinal diseases (except appendectomy or hernia surgery) that may affect the absorption of the investigational products
• Female subjects who are pregnant, suspected of pregnancy, or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Sequence A (R1+R2+R3 / T)

Experimental group

Description:

R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006

Treatment:

Drug: Pioglitazone 30 mg

Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg

Drug: Dapagliflozin 10 mg

Drug: Metformin HCl 1000 mg

Sequence B (T / R1+R2+R3)

Experimental group

Description:

T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C

Treatment:

Drug: Pioglitazone 30 mg

Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg

Drug: Dapagliflozin 10 mg

Drug: Metformin HCl 1000 mg