Diabete Mellitus
Conditions
Keywords
Dapagliflozin, Pioglitazone, Metformin HCl
Brief summary
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
Orally administered once per day
DRUGDapagliflozin 10 mg
Orally administered once per day
Orally administered once per day
Orally administered once per day
Sponsors
Boryung Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic variable - AUCt | [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration] | Area under the drug concentration-time curve over the time interval of BR3006 |
| Pharmacokinetic variable - Cmax | [Time Frame: From Day 1, 0 hour (pre-dose) to Day 3 after dose administration] | Maximum plasma concentration of BR3006 |
Countries
South Korea
Contacts
Primary ContactShinyoung Oh
Outcome results
None listed