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

Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03876210
• Other study ID #: PK101_P102
• Status: Completed
• Phase: Phase 1
• Start date: July 12, 2019
• Est. completion date: August 5, 2019

Study information

• Verified date: September 2019
• Source: PMG Pharm Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: August 5, 2019
• Est. primary completion date: July 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis

Intervention

Combination Product:
• PK101
PK101-001 + PK101-002 (combination)

Drug:
• PK101-001, PK101-002
coadministration

Locations

Country	Name	City	State
Korea, Republic of	Clinical Trials Center, Chungnam National University Hospital	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
PMG Pharm Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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