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

PMG Pharm

Status and phase: Completed; Phase 1

Conditions: Arthritis

Treatments: Drug: PK101-001, PK101-002; Combination Product: PK101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03876210

PK101_P102

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Sequence A

Other group

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

Treatment:

Combination Product: PK101

Drug: PK101-001, PK101-002

Sequence B

Other group

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

Treatment:

Combination Product: PK101

Drug: PK101-001, PK101-002