A Study to Evaluate the Pharmacokinetics and Safety Between "BR3006" and Co-administration of "BR3006A", "BR3006B", and "BR3006C" in Healthy Adult Volunteers (Fed)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorBoryung Pharmaceutical Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Dapagliflozin 10 mg/Pioglitazone 30 mg/Metformin HCl 1000 mg

    Drug

    Orally administered once per day

  • Dapagliflozin 10 mg

    Drug

    Orally administered once per day

  • Pioglitazone 30 mg

    Drug

    Orally administered once per day

  • Metformin HCl 1000 mg

    Drug

    Orally administered once per day

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Sequence A (R1+R2+R3 / T)Experimental treatment 4 interventions
Group B: Sequence B (T / R1+R2+R3)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pharmacokinetic variable - AUCt

Area under the drug concentration-time curve over the time interval of "BR3006"

Time frame
[Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]
2

Pharmacokinetic variable - Cmax

Maximum plasma concentration of "BR3006"

Time frame
[Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration]

Secondary outcomes

Other outcomes

Sponsors and contacts

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