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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 19 and up

Single-pill combination of dapagliflozin, pioglitazone, and metformin versus taking the three drugs separately (fed)

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

Run by Boryung Pharmaceutical Co., Ltd · NCT07083401 · Data updated 2026-11-12

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.

More Diabete Mellitus trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment40 (estimated)
SponsorBoryung Pharmaceutical Co., Ltd
Industry-sponsored
Locations1 site (Seoul, Gwanak-gu)
StatusRecruiting
StartedJuly 5, 2025
Main results expectedJuly 5, 2026
Study endsJuly 5, 2026
Registry record updatedJuly 24, 2025
Trial IDNCT07083401 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • H Plus Yangji Hospital
    Seoul, Gwanak-gu, South Korea     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.