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

May 23, 2019 updated by: PMG Pharm Co., Ltd

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • A
Combination product: PK101
-(Combination) PK101-001, PK101-002
Other Names:
  • 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 Names:
  • A
Combination product: PK101
-(Combination) PK101-001, PK101-002
Other Names:
  • B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour
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
0, 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PMG Pharm Co., Ltd

Investigators

  • Principal Investigator: Seung-Hyun Kang, H Plus Yangji Clinical Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2019

Primary Completion (Actual)

March 22, 2019

Study Completion (Actual)

April 24, 2019

Study Registration Dates

First Submitted

May 27, 2018

First Submitted That Met QC Criteria

June 11, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PK101_P101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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