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

Overview

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

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 22, 2019

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Sequence (1)
    • Number of Subject: 24 Wash out Period: over 7 days (between each period) Investigators Products(IPs) for Period1: A (Single)= PK101-002 IPs for Period2: B (Combination)= PK101-001, PK101-002
  • Experimental: Sequence (2)
    • Number of Subject: 24 Wash out Period: over 7 days (between each period) IPs for Period1: B (Combination)= PK101-001, PK101-002 IPs for Period2: A (Single)= PK101-002

Clinical Trial Outcome Measures

Primary Measures

  • AUCτ
    • Time Frame: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
    • Area under the plasma drug concentration-time curve for PK101-002 at Steady-state (between dose times)
  • Cmax,ss
    • Time Frame: 0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
    • The maximum (or peak) serum concentration for PK101-002 at Steady-state

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • PMG Pharm Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seung-Hyun Kang, Principal Investigator, H Plus Yangji Clinical Research Center

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