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

NCT03553316 | Completed Phase 1

• 1 other identifier: PK101_P101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthritis

Outcome Measures

Primary Outcomes (2)

• AUCτ

  Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)

  0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

• Cmax,ss

  The maximum (or peak) serum concentration for PK101-002 at Steady-state

  0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

Study Arms (2)

Sequence (1)

EXPERIMENTAL

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

Drug: PK101-002; Combination Product: PK101

Sequence (2)

EXPERIMENTAL

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

Drug: PK101-002; Combination Product: PK101

Interventions

PK101-002 DRUG

-(Single) PK101-002

Also known as: A

Sequence (1); Sequence (2)

PK101 COMBINATION_PRODUCT

-(Combination) PK101-001, PK101-002

Also known as: B

Sequence (1); Sequence (2)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• mmHg ≤ (SBP) ≤ 139mmHg, 60mmHg ≤ (DBP) ≤ 89mmHg
• Kg/(m)\^2 ≤ (BMI) ≤30Kg/(m)\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• PMG Pharm Co., Ltd: lead

Study Sites (1)

H Plus Yangji Clinical Research Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Seung-Hyun Kang

  H Plus Yangji Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2018
• First Posted: June 12, 2018
• Study Start: February 28, 2019
• Primary Completion: March 22, 2019
• Study Completion: April 24, 2019
• Last Updated: May 24, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)