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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic variable - Cmax
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •Those who are pregnant, suspected of pregnancy, or nursing
Arms & Interventions
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
Intervention: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg (Drug)
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
Intervention: Dapagliflozin 10 mg (Drug)
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
Intervention: Pioglitazone 30 mg (Drug)
Sequence A (R1+R2+R3 / T)
R1+R2+R3: BR3006A, BR3006B, and BR3006C; T: BR3006
Intervention: Metformin HCl 1000 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
Intervention: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
Intervention: Dapagliflozin 10 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
Intervention: Pioglitazone 30 mg (Drug)
Sequence B (T / R1+R2+R3)
T: BR3006; R1+R2+R3: BR3006A, BR3006B, and BR3006C
Intervention: Metformin HCl 1000 mg (Drug)
Outcomes
Primary Outcomes
Pharmacokinetic variable - Cmax
Time Frame: 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
Time Frame: 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 Outcomes
No secondary outcomes reported