Drug-Drug Interaction Between PK101-001 and PK101-002

• Status: Completed
• Trial end date: 2019-04-24
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the drug-drug interaction of PK101-001 and PK101-002 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)

• 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