A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg, Dapagliflozin 10 mg, Pioglitazone 30 mg, Metformin HCl 1000 mg.
- Who it may be relevant to
- Registry conditions: Diabete Mellitus. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed 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.
Interventions
- Drug Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg
Orally administered once per day - Drug Dapagliflozin 10 mg
Orally administered once per day - Drug Pioglitazone 30 mg
Orally administered once per day - Drug Metformin HCl 1000 mg
Orally administered once per day
Primary outcome measures
- Pharmacokinetic variable - AUCt [Time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]]
- Pharmacokinetic variable - Cmax [Time frame: [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- H Plus Yangji Hospital — Seoul
Identifiers
NCT: NCT07083401 · BR-DPMC-CT-105