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

Study Overview
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Brief Summary
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To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.

Official Title
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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.

Conditions
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Arthritis

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


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) 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

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 |
| --- | --- |
| Experimental: Sequence (1)<br>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 | Drug: PK101-002<br>* -(Single) PK101-002<br>* Other names: A;Combination Product: PK101<br>* -(Combination) PK101-001, PK101-002<br>* Other names: B;|
| Experimental: Sequence (2)<br>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 | Drug: PK101-002<br>* -(Single) PK101-002<br>* Other names: A;Combination Product: PK101<br>* -(Combination) PK101-001, PK101-002<br>* Other names: B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCτ | Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times) | 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour | 
| Cmax,ss | The maximum (or peak) serum concentration for PK101-002 at Steady-state | 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour |