Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs

• Status: Completed
• Trial end date: 2019-08-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PMG Pharm Co., Ltd

Criteria

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.