Drug-Drug Interaction Between PK101-001 and PK101-002
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PK101-002
PK101
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
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
Sites / Locations
- H Plus Yangji Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence (1)
Sequence (2)
Arm Description
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
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
Outcomes
Primary Outcome Measures
AUCτ
Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)
Cmax,ss
The maximum (or peak) serum concentration for PK101-002 at Steady-state
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03553316
Brief Title
Drug-Drug Interaction Between PK101-001 and PK101-002
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
April 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PMG Pharm Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence (1)
Arm Type
Experimental
Arm Description
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
Arm Title
Sequence (2)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
PK101-002
Other Intervention Name(s)
A
Intervention Description
-(Single) PK101-002
Intervention Type
Combination Product
Intervention Name(s)
PK101
Other Intervention Name(s)
B
Intervention Description
-(Combination) PK101-001, PK101-002
Primary Outcome Measure Information:
Title
AUCτ
Description
Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)
Time Frame
0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Title
Cmax,ss
Description
The maximum (or peak) serum concentration for PK101-002 at Steady-state
Time Frame
0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-Hyun Kang
Organizational Affiliation
H Plus Yangji Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Plus Yangji Clinical Research Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Drug-Drug Interaction Between PK101-001 and PK101-002
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