Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs
Phase 1
Completed
- Conditions
- Arthritis
- Interventions
- Combination Product: PK101Drug: PK101-001, PK101-002
- Registration Number
- NCT03876210
- Lead Sponsor
- PMG Pharm Co., Ltd
- Brief Summary
The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
- Healthy adults ≥ 19 years of age (on the day of screening)
- Body weigth ≥50.0kg, 18.5Kg/(m)^2 ≤ (BMI) ≤30.0Kg/(m)^2
- No congenital or chronic diseases and no abnormal signs determined by medical examinations
- Not abnormal or not clinical significant lab values
- Understand the requirements of the study and voluntarily consent to participate in the study.
Exclusion Criteria
- Clinically significant disease with liver, renal, neurologic, respiratory, digestive, endocrine, hemato-oncology, urologic, cardiovascular, musculoskeletal, psychiatric system
- Subjects who have hypersensitivity for investigational products
- AST or ALT > 2*ULN, r-GTP > 1.5*ULN, Blood creatinine > ULN (ULN, Upper Limit of Normal)
- SBP ≥ 140 mmHg or< 90 mmHg, DBP ≥ 90 mmHg or < 60 mmHg
- Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
- Subjects who previously participated in other clinical trials or bioequivalence Test within 6 months
- Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence A PK101 Period 1: PK101-001, PK101-002 / Period 2: PK101 Number of subject: 23 Wash out Period: over 7 days (between each period) Dosage: Once daily, at 2D each period Sequence A PK101-001, PK101-002 Period 1: PK101-001, PK101-002 / Period 2: PK101 Number of subject: 23 Wash out Period: over 7 days (between each period) Dosage: Once daily, at 2D each period Sequence B PK101 Period 1: PK101 / Period 2: PK101-001, P101-002 Number of subject: 23 Wash out Period: over 7 days (between each period) Dosage: Once daily, at 2D each period Sequence B PK101-001, PK101-002 Period 1: PK101 / Period 2: PK101-001, P101-002 Number of subject: 23 Wash out Period: over 7 days (between each period) Dosage: Once daily, at 2D each period
- Primary Outcome Measures
Name Time Method AUCt 0(Pre-dose), 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/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002
Cmax 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour Maximum Plasma Concentration of PK101-002
- Secondary Outcome Measures
Name Time Method Tmax 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour Time of peak concentration of PK101-002
AUCinf 0(Pre-dose), 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 concentration versus time curve from zero to infinity of PK101-002
t1/2 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour Terminal half life of PK101-002
CL/F 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour Clearance/Bioavailability of PK101-002
AUCt/AUCinf 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour AUCt/AUCinf of PK101-002
Trial Locations
- Locations (1)
Clinical Trials Center, Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of