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OpenTrials
Completed

NCT Number: NCT03553316

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

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

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

H Plus Yangji Clinical Research Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PK101-002

Drug

-(Single) PK101-002

Other names: A

PK101

Combination Product

-(Combination) PK101-001, PK101-002

Other names: B

Primary outcomes

  1. 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)

  2. 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

Sponsors and collaborators

Lead sponsor

PMG Pharm Co., Ltd

Industry

Registry information

Official study 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.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
May 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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