Clinical trial NCT03876210: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis
Lead sponsor: PMG Pharm Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-03-15
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: AUCt
timeFrame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
measure: Cmax
timeFrame: 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 outcomes:
measure: Tmax
timeFrame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
measure: AUCinf
timeFrame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
measure: t1/2
timeFrame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
measure: CL/F
timeFrame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
measure: AUCt/AUCinf
timeFrame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Clinical Trials Center, Chungnam National University Hospital
Study officials:
affiliation: Clinical Trials Center, Chungnam National University Hospital
name: Jang-Hee Hong
role: PRINCIPAL_INVESTIGATOR
References: