Status:
COMPLETED
Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs
Lead Sponsor:
PMG Pharm Co., Ltd
Conditions:
Arthritis
Eligibility:
All Genders
19+ years
Phase:
PHASE1
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 volunteer...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 5 2019
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT03876210
Start Date
July 12 2019
End Date
August 5 2019
Last Update
September 25 2019
Active Locations (1)
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1
Clinical Trials Center, Chungnam National University Hospital
Daejeon, South Korea