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

NCT ID: NCT03553316

Last Updated: 2019-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2019-04-24

Brief Summary

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

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Detailed Description

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Conditions

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Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence (1)

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

Group Type EXPERIMENTAL

PK101-002

Intervention Type DRUG

-(Single) PK101-002

PK101

Intervention Type COMBINATION_PRODUCT

-(Combination) PK101-001, PK101-002

Sequence (2)

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

Group Type EXPERIMENTAL

PK101-002

Intervention Type DRUG

-(Single) PK101-002

PK101

Intervention Type COMBINATION_PRODUCT

-(Combination) PK101-001, PK101-002

Interventions

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PK101-002

-(Single) PK101-002

Intervention Type DRUG

PK101

-(Combination) PK101-001, PK101-002

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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A B

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PMG Pharm Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Seung-Hyun Kang

Role: PRINCIPAL_INVESTIGATOR

H Plus Yangji Clinical Research Center

Locations

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H Plus Yangji Clinical Research Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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PK101_P101

Identifier Type: -

Identifier Source: org_study_id

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