A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fasting)
- Conditions
- Diabetes Mellitus
- Interventions
- Drug: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mgDrug: Metformin HCl 1000 mg
- Registration Number
- NCT07083388
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
This was an open-label, randomized, fasting, 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.
- Detailed Description
A total of 52 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 fasting.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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
- Those who are pregnant, suspected of pregnancy, or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A (R1+R2+R3 / T) Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006 Sequence A (R1+R2+R3 / T) Dapagliflozin 10 mg R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006 Sequence A (R1+R2+R3 / T) Pioglitazone 30 mg R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006 Sequence A (R1+R2+R3 / T) Metformin HCl 1000 mg R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006 Sequence B (T / R1+R2+R3) Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C Sequence B (T / R1+R2+R3) Dapagliflozin 10 mg T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C Sequence B (T / R1+R2+R3) Pioglitazone 30 mg T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C Sequence B (T / R1+R2+R3) Metformin HCl 1000 mg T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
- Primary Outcome Measures
Name Time Method Pharmacokinetic variable - Cmax From Day 1, 0 hour (pre-dose) to Day 5 after dose administration Maximum plasma concentration of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"
Pharmacokinetic variable - AUCt From Day 1, 0 hour (pre-dose) to Day 5 after dose administration Area under the drug concentration-time curve over the time interval of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H Plus Yangji Hospital
🇰🇷Seoul, Gwanak-gu, Korea, Republic of
H Plus Yangji Hospital🇰🇷Seoul, Gwanak-gu, Korea, Republic of