Type2 Diabetes
Conditions
Brief summary
A study demonstrates the bioequivalence of DA-1229\_01(A) at Fed State when compared with Sugamet sustained-release(SR) Tab 5/1000mg® in healthy adults
Interventions
Period 1: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar. The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229\_01(A)) together with 150 mL of water containing 30 g sugar.
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients over 19 years of age at the time of health examination * Female patients who were confirmed to be not pregnant at health examination * Patients without a history of mental illness in the past 5 years
Exclusion criteria
* Patients who have taken medications which could affect the results of the clinical trial in the past 10 days of participating in the clinical trial * Patients with a congestive heart failure which requires medicinal treatment * Patients who have made a whole blood donation in the past 2 months or an apheresis donation in the past 2 weeks of participating in the clinical trial * Female patients who are lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration-time curve(AUCt) | Hour -1 ~ Hour 24 | AUCt of metformin |
| Maximum plasmaconcentration of drug in plasma(Cmax) | Hour -1 ~ Hour 24 | Cmax of metformin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach the maximum plasma concentration(Tmax) | Hour -1 ~ Hour 24 | Tmax of metformin |
| Area under the plasma drug concentration-time curve from time 0 to infinity(AUCinf) | Hour -1 ~ Hour 24 | AUCinf of metformin |
| Terminal elimination half-life(t1/2) | Hour -1 ~ Hour 24 | t1/2 of metformin |
| Terminal elimination rate constant(ramda z) | Hour -1 ~ Hour 24 | ramda z of metformin |
| AUCt/AUCinf | Hour -1 ~ Hour 24 | AUCt/AUCinf of metformin |
Countries
South Korea
Outcome results
None listed