Single-pill combination of dapagliflozin, pioglitazone, and metformin versus taking the three drugs separately (fed)
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
This test will see if a single combination pill of dapagliflozin/pioglitazone/metformin gives the same blood drug levels and safety as taking the three drugs separately in healthy adults after a meal.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Boryung Pharmaceutical Co., Ltd Industry-sponsored |
| Locations | 1 site (Seoul, Gwanak-gu) |
| Trial ID | NCT07083401 on ClinicalTrials.gov |
What this trial studies
This open-label, randomized, fed, single-dose, two-sequence, two-period crossover study will enroll 40 healthy adult volunteers. Each participant will receive one dose of the combination tablet (dapagliflozin 10 mg / pioglitazone 30 mg / metformin HCl 1000 mg) and, in the other period, the three individual tablets, with a washout between periods. Serial blood samples will be taken to measure pharmacokinetic parameters and participants will be monitored for safety with labs, ECGs, and adverse event reporting. The goal is to compare systemic exposure (for example Cmax and AUC) and tolerability under fed conditions.
Who should consider this trial
Good fit: Healthy adults aged 19 years or older who can give informed consent and pass screening labs, ECG, and other eligibility checks are ideal candidates.
Not a fit: People with recent participation in another investigational product within 6 months, a history of gastrointestinal surgery or active gastrointestinal disease, or active medical conditions that would exclude them (including many people with treated diabetes) are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the single-tablet combination could simplify treatment by replacing three pills with one, potentially improving convenience and adherence.
How similar studies have performed: Similar single-dose, crossover bioequivalence and pharmacokinetic studies comparing combination tablets to co-administration of individual diabetes drugs have been done previously and often show comparable drug exposure, though each formulation requires its own testing.
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 * Female subjects 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.