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

Study Overview
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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.

Official Title
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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

Conditions
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Arthritis

Intervention / Treatment
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* Combination Product: PK101
* Drug: PK101-001, PK101-002


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sequence A<br>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 | Combination Product: PK101<br>* PK101-001 + PK101-002 (combination)<br>Drug: PK101-001, PK101-002<br>* coadministration<br>|
| Other: Sequence B<br>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 | Combination Product: PK101<br>* PK101-001 + PK101-002 (combination)<br>Drug: PK101-001, PK101-002<br>* coadministration<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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