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

Primary Purpose

Arthritis

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

PK101-002

PK101

About this trial

This is an interventional treatment trial for Arthritis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

H Plus Yangji Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sequence (1)

Sequence (2)

Arm 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

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

Outcomes

Primary Outcome Measures

AUCτ

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

Cmax,ss

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03553316

First Posted

May 27, 2018

Last Updated

May 23, 2019

Sponsor

PMG Pharm Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT03553316

Brief Title

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

Official Title

A Randomized, Open Labeled, Multiple Dose, 2-Sequence, 2-Period Cross-over Phase 1 Study to Evaluate the Drug-Drug Interaction of PK101-001 and PK101-002 in Healthy Volunteers.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 28, 2019 (Actual)

Primary Completion Date

March 22, 2019 (Actual)

Study Completion Date

April 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PMG Pharm Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sequence (1)

Arm Type

Experimental

Arm 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

Arm Title

Sequence (2)

Arm Type

Experimental

Arm 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

Intervention Type

Drug

Intervention Name(s)

PK101-002

Other Intervention Name(s)

Intervention Description

-(Single) PK101-002

Intervention Type

Combination Product

Intervention Name(s)

PK101

Other Intervention Name(s)

Intervention Description

-(Combination) PK101-001, PK101-002

Primary Outcome Measure Information:

Title

AUCτ

Description

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

Time Frame

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

Title

Cmax,ss

Description

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung-Hyun Kang

Organizational Affiliation

H Plus Yangji Clinical Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

H Plus Yangji Clinical Research Center

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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