Back to resultsStudy to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs
Primary Purpose
Arthritis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PK101
PK101-001, PK101-002
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)
- 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.
Sites / Locations
- Clinical Trials Center, Chungnam National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Sequence A
Sequence B
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Cmax
Maximum Plasma Concentration of PK101-002
Secondary Outcome Measures
Tmax
Time of peak concentration of PK101-002
AUCinf
Area under the plasma concentration versus time curve from zero to infinity of PK101-002
t1/2
Terminal half life of PK101-002
CL/F
Clearance/Bioavailability of PK101-002
AUCt/AUCinf
AUCt/AUCinf of PK101-002
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03876210
Brief Title
Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
July 12, 2019 (Actual)
Primary Completion Date
July 22, 2019 (Actual)
Study Completion Date
August 5, 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
5. Study Description
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.
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
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Other
Arm Description
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
Arm Title
Sequence B
Arm Type
Other
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
PK101
Intervention Description
PK101-001 + PK101-002 (combination)
Intervention Type
Drug
Intervention Name(s)
PK101-001, PK101-002
Intervention Description
coadministration
Primary Outcome Measure Information:
Title
AUCt
Description
Area under the plasma/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002
Time Frame
0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Title
Cmax
Description
Maximum Plasma Concentration of PK101-002
Time Frame
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 Measure Information:
Title
Tmax
Description
Time of peak concentration of PK101-002
Time Frame
0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Title
AUCinf
Description
Area under the plasma concentration versus time curve from zero to infinity of PK101-002
Time Frame
0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Title
t1/2
Description
Terminal half life of PK101-002
Time Frame
0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Title
CL/F
Description
Clearance/Bioavailability of PK101-002
Time Frame
0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Title
AUCt/AUCinf
Description
AUCt/AUCinf of PK101-002
Time Frame
0(Pre-dose), 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)
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jang-Hee Hong
Organizational Affiliation
Clinical Trials Center, Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Trials Center, Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs
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