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

A Randomized, Open-label, Single Dose, 2x2 Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination or Loose Combination of PK101 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03876210

Enrollment

Registered

2019-03-15

Start date

2019-07-12

Completion date

2019-08-05

Last updated

2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis

Brief summary

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.

Interventions

COMBINATION_PRODUCTPK101

PK101-001 + PK101-002 (combination)

DRUGPK101-001, PK101-002

coadministration

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
AUCt	0(Pre-dose), 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/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002
Cmax	0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour	Maximum Plasma Concentration of PK101-002

Secondary

Measure	Time frame	Description
t1/2	0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour	Terminal half life of PK101-002
Tmax	0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour	Time of peak concentration of PK101-002
AUCt/AUCinf	0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour	AUCt/AUCinf of PK101-002
CL/F	0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour	Clearance/Bioavailability of PK101-002
AUCinf	0(Pre-dose), 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 concentration versus time curve from zero to infinity of PK101-002

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026