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

Phase 1

Completed

• Conditions: Arthritis
• Interventions: Drug: PK101-002; Combination Product: PK101

• Registration Number: NCT03553316
• Lead Sponsor: PMG Pharm Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-27
• Study First Submitted QC: 2018-06-11
• Study First Posted: 2018-06-12
• Status Verified: 2018-08
• Study Start: 2019-02-28
• Primary Completion: 2019-03-22
• Study Completion: 2019-04-24
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence (2)	PK101-002	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
Sequence (1)	PK101	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
Sequence (2)	PK101	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
Sequence (1)	PK101-002	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

Primary Outcome Measures

Name	Time	Method
Cmax,ss	0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour	The maximum (or peak) serum concentration for PK101-002 at Steady-state
AUCτ	0, 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 drug concentration-time curve for PK101-002 at Steady-state (between dose times)

Trial Locations

Locations (1)

H Plus Yangji Clinical Research Center; 🇰🇷 Seoul, Korea, Republic of