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ArthritisPhase 1NCT03876210

Study to Compare the Safety and Pharmacokinetics of PK101 With Coadministration of the Two Separate Drugs

A Phase 1 study testing PK101 and PK101-001, PK101-002 in people with Arthritis, run by PMG Pharm Co., Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Arthritis
What is being tested?
PK101 and PK101-001, PK101-002
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteSouth Korea
Study dates
12 Jul 2019to 5 Aug 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Clinical Trials Center, Chungnam National University Hospital

    Daejeon

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, 2x2 Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of Fixed-dose Combination or Loose Combination of PK101 in Healthy Volunteers

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.

Conditions
Arthritis
Being tested
PK101, PK101-001, PK101-002
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PK101Combination product

    PK101-001 + PK101-002 (combination)

  • PK101-001, PK101-002Drug

    coadministration

Study groups in NCT03876210
Study groupRoleWhat they receive
Sequence AOtherPeriod 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
Receives: Combination Product: PK101; Drug: PK101-001, PK101-002
Sequence BOtherPeriod 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
Receives: Combination Product: PK101; Drug: PK101-001, PK101-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. Cmax

    Maximum Plasma Concentration of PK101-002

    Measured: 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)

  1. Tmax

    Time of peak concentration of PK101-002

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

  2. AUCinf

    Area under the plasma concentration versus time curve from zero to infinity of PK101-002

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

  3. t1/2

    Terminal half life of PK101-002

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

  4. CL/F

    Clearance/Bioavailability of PK101-002

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

  5. AUCt/AUCinf

    AUCt/AUCinf of PK101-002

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2019
  2. Study start12 Jul 2019
  3. Primary completion22 Jul 2019
  4. Study completion5 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03876210
Sponsor's protocol ID
PK101_P102
Status last verified
Sep 2019
First submitted
13 Mar 2019
Last updated
25 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39560548

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PK101 and PK101-001, PK101-002 in people with Arthritis, run by PMG Pharm Co., Ltd at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCt (time frame: 0(Pre-dose), 0.5, 1, 1.5, 2, 2.33, 2.67, 3, 3.5, 4, 6, 8, 12, 24, 36, 48 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03876210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.

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