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

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ClinicalTrials.gov Identifier: NCT03553316
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
PMG Pharm Co., Ltd

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

Condition or disease Intervention/treatment Phase
Arthritis Drug: PK101-002 Combination Product: PK101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : February 28, 2019
Actual Primary Completion Date : March 22, 2019
Actual Study Completion Date : April 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions

Arm Intervention/treatment
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

Drug: PK101-002
-(Single) PK101-002
Other Name: A

Combination Product: PK101
-(Combination) PK101-001, PK101-002
Other Name: B

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

Drug: PK101-002
-(Single) PK101-002
Other Name: A

Combination Product: PK101
-(Combination) PK101-001, PK101-002
Other Name: B




Primary Outcome Measures :
  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



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553316


Locations
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Korea, Republic of
H Plus Yangji Clinical Research Center
Seoul, Korea, Republic of
Sponsors and Collaborators
PMG Pharm Co., Ltd
Investigators
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Principal Investigator: Seung-Hyun Kang H Plus Yangji Clinical Research Center

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Responsible Party: PMG Pharm Co., Ltd
ClinicalTrials.gov Identifier: NCT03553316     History of Changes
Other Study ID Numbers: PK101_P101
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases