Compare a single combo pill of dapagliflozin, pioglitazone, and metformin with taking the three drugs separately in fasting adults
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
This will test whether a single combination tablet of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin 1000 mg gives similar drug levels and is as safe as taking the three medicines separately in healthy adults when fasting.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Trial ID | NCT07083388 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized, single-dose, two-sequence, two-period crossover Phase 1 study will enroll 52 healthy adult volunteers to compare the pharmacokinetics and safety of a fixed-dose combination tablet versus co-administration of the three separate tablets while fasting. Each participant receives both treatments in separate periods to allow within-subject comparison of blood drug concentrations and adverse events. Safety monitoring includes laboratory tests, ECGs, and recording of adverse events. The primary focus is demonstrating comparable pharmacokinetic profiles between the combination tablet and the separate products, with safety and tolerability as secondary measures.
Who should consider this trial
Good fit: Healthy adults aged 19 years or older who meet laboratory and ECG screening criteria and can give informed written consent are the intended participants.
Not a fit: People who recently received another investigational product, have had gastrointestinal surgery, or have active gastrointestinal disease (and therefore are ineligible) would not benefit from participating in this study.
Why it matters
Potential benefit: If successful, a single fixed-dose tablet could simplify dosing and improve convenience and adherence for people who take these three diabetes medicines.
How similar studies have performed: Fixed-dose combination versus co-administration pharmacokinetic and safety studies for diabetes drugs are common and have frequently shown comparable pharmacokinetics, so this approach is established rather than novel.
Eligibility criteria
Show full inclusion / exclusion 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 * Those who are pregnant, suspected of pregnancy, or nursing
Where this trial is running
Seoul, Gwanak-gu
- H Plus Yangji Hospital — Seoul, Gwanak-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Shinyoung Oh
- Email: syoh@boryung.co.kr
- Phone: +82 2-708-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.