NCT03876210

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 12, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2019

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2019

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2019

Enrollment Period

10 days

First QC Date

March 13, 2019

Last Update Submit

September 23, 2019

Conditions

Arthritis

Outcome Measures

Primary Outcomes (2)

  • AUCt

    Area under the plasma/serum/blood drug concentration-time curve from time zero to the time of the last quantifiable concentration of PK101-002

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

  • Cmax

    Maximum Plasma Concentration of PK101-002

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

Secondary Outcomes (5)

  • Tmax

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

  • AUCinf

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

  • t1/2

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

  • CL/F

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

  • AUCt/AUCinf

    0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour

Study Arms (2)

Sequence A

OTHER

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

Combination Product: PK101Drug: PK101-001, PK101-002

Sequence B

OTHER

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

Combination Product: PK101Drug: PK101-001, PK101-002

Interventions

PK101COMBINATION_PRODUCT

PK101-001 + PK101-002 (combination)

Sequence ASequence B
PK101-001, PK101-002DRUG

coadministration

Sequence ASequence B

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials Center, Chungnam National University Hospital

Daejeon, South Korea

Location

Related Publications (1)

  • Song JH, Koh H, Moon HY, Jung JG, Hong JH, Sunwoo J. Comparison of a fixed-dose combination of Celecoxib/PG201 [Layla(R)] versus co-administration of individual formulations in healthy participants: A randomized trial. Medicine (Baltimore). 2024 Nov 15;103(46):e40494. doi: 10.1097/MD.0000000000040494.

    PMID: 39560548DERIVED

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Jang-Hee Hong

    Clinical Trials Center, Chungnam National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

July 12, 2019

Primary Completion

July 22, 2019

Study Completion

August 5, 2019

Last Updated

September 25, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)