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

Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03553316
• Other study ID #: PK101_P101
• Status: Completed
• Phase: Phase 1
• Start date: February 28, 2019
• Est. completion date: April 24, 2019

Study information

• Verified date: August 2018
• Source: PMG Pharm Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the drug-drug interaction of PK101-001 and PK101-002 in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 24, 2019
• Est. primary completion date: March 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)

• 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

Related Conditions & MeSH terms

• Arthritis

Intervention

Drug:
• PK101-002
-(Single) PK101-002

Combination Product:
• PK101
-(Combination) PK101-001, PK101-002

Locations

Country	Name	City	State
Korea, Republic of	H Plus Yangji Clinical Research Center	Seoul

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 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
Primary	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