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

PMG Pharm

Status and phase: Completed; Phase 1

Conditions: Arthritis

Treatments: Combination Product: PK101; Drug: PK101-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT03553316

PK101_P101

Details and patient eligibility

About

To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.

Enrollment: 49 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

Sequence (1)

Experimental group

Description:

Number of Subject: 24 Wash out Period: over 7 days (between each period) Investigators Products(IPs) for Period1: A (Single)= PK101-002 IPs for Period2: B (Combination)= PK101-001, PK101-002

Treatment:

Drug: PK101-002

Combination Product: PK101

Sequence (2)

Experimental group

Description:

Number of Subject: 24 Wash out Period: over 7 days (between each period) IPs for Period1: B (Combination)= PK101-001, PK101-002 IPs for Period2: A (Single)= PK101-002

Treatment:

Drug: PK101-002

Combination Product: PK101