Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs

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

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-12

Study Completion Date

2019-08-05

Brief Summary

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The purpose of this study is to compare the safety and pharmacokinetics of PK101(fixed-dose combination of PK101-001 and PK101-002) with coadministration of the two separate drugs 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 A

Period 1: PK101-001, PK101-002 / Period 2: PK101

Number of subject: 23

Wash out Period: over 7 days (between each period)

Dosage: Once daily, at 2D each period

Group Type OTHER

PK101

Intervention Type COMBINATION_PRODUCT

PK101-001 + PK101-002 (combination)

PK101-001, PK101-002

Intervention Type DRUG

coadministration

Sequence B

Period 1: PK101 / Period 2: PK101-001, P101-002

Number of subject: 23

Wash out Period: over 7 days (between each period)

Dosage: Once daily, at 2D each period

Group Type OTHER

PK101

Intervention Type COMBINATION_PRODUCT

PK101-001 + PK101-002 (combination)

PK101-001, PK101-002

Intervention Type DRUG

coadministration

Interventions

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PK101

PK101-001 + PK101-002 (combination)

Intervention Type COMBINATION_PRODUCT

PK101-001, PK101-002

coadministration

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults ≥ 19 years of age (on the day of screening)
* Body weigth ≥50.0kg, 18.5Kg/(m)\^2 ≤ (BMI) ≤30.0Kg/(m)\^2
* No congenital or chronic diseases and no abnormal signs determined by medical examinations
* Not abnormal or not clinical significant lab values
* Understand the requirements of the study and voluntarily consent to participate in the study.

Exclusion Criteria

* Clinically significant disease with liver, renal, neurologic, respiratory, digestive, endocrine, hemato-oncology, urologic, cardiovascular, musculoskeletal, psychiatric system
* Subjects who have hypersensitivity for investigational products
* AST or ALT \> 2\*ULN, r-GTP \> 1.5\*ULN, Blood creatinine \> ULN (ULN, Upper Limit of Normal)
* SBP ≥ 140 mmHg or\< 90 mmHg, DBP ≥ 90 mmHg or \< 60 mmHg
* Subjects who were administered below medications within 30 days (barbiturates, drugs of induced or suppressive drug metabolizing enzyme, etc)
* Subjects who previously participated in other clinical trials or bioequivalence Test within 6 months
* Subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes