Arthritis
Conditions
Brief summary
To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.
Interventions
Sponsors
PMG Pharm 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
* Healthy adults ≥ 19 years of age (on the day of screening) * No congenital or chronic diseases and no abnormal signs determined by medical examinations * Not abnormal or not clinical significant lab values * 90mmHg ≤ (SBP) ≤ 139mmHg, 60mmHg ≤ (DBP) ≤ 89mmHg * 18Kg/(m)\^2 ≤ (BMI) ≤30Kg/(m)\^2
Exclusion criteria
* Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc) * Subjects who were administered medications of prohibition within 10 days * Heavy drinking within 30 days (female: over 14units/week, male:over 21units/week) * Heavy smoker within 30 days (over 20 cigarettes per day) * Subjects who previously participated in other clinical trials or bioequivalence Test within 90 days * Subjects who donated whole blood within 60 days or donated component blood within 14 days or received blood transfusion within 30 days * Subjects who have hypersensitivity for investigational products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCτ | 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour | Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times) |
| Cmax,ss | 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour | The maximum (or peak) serum concentration for PK101-002 at Steady-state |
Countries
South Korea
Outcome results
None listed