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HealthyPhase 1NCT03261427

Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration Adult Volunteers

A Phase 1 study testing Lyrica 150Mg Capsule and YNP-1807 330Mg Tablet in people with Healthy, run by Yungjin 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 trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Lyrica 150Mg Capsule and YNP-1807 330Mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSouth Korea
Study dates
14 Sep 2017to 29 Mar 2018
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 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 19 years to 55 years healthy volunteers adult at screening visit
  • For male, weight is more than 55 kg, for female, weight is more than 50 kg.
  • Body mass index(BMI) value : 18.5 to 25.0 kg/m2
  • If female, should be included one at least as following
  • menopausal(menstruation for 2 years minimum)
  • surgery infertility

Who cannot join

  • Any history of drug overdose or dependence
  • Female who is pregnant or nursing
  • AST, ALT > ULN*1.25
  • Total bilirubin > ULN*1.5
  • CPK > ULN*1.5

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, Yonsei-ro Seodaemun-gu, 120-752

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Phase I Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety/Tolerability of YNP-1807 Compared to Lyrica® After Oral Administration in Healthy Adult Volunteers: Part I- Single Dosing/Part II- Multiple Dosing

The purpose of this trial to compare the pharmacokinetic characteristics of YNP-1807(Pregabalin 330mg) and Lyrica capsule(Pregabalin 150mg). YNP-1807 is made by Yungjin Pharm. Primary endpoints are AUClast and Cmax and secondary endpoints are AUCinf, Tmax, t1/2, Vd/f, CL/f.

Conditions
Healthy
Being tested
Lyrica 150Mg Capsule, YNP-1807 330Mg Tablet

What participants receive

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

  • Lyrica 150Mg CapsuleDrug

    150 mg oral administered (BID)

  • YNP-1807 330Mg TabletDrug

    330 mg oral administered (QD)

Study groups in NCT03261427
Study groupRoleWhat they receive
YNP-1807 Tablet(Pregabalin 330mg)ExperimentalYNP-1807(Pregabalin 330mg), QD
Receives: Drug: YNP-1807 330Mg Tablet
Lyrica Capsule(Pregabalin 150mg)Active comparatorLyrica Capsule(Pregabalin 150mg), BID
Receives: Drug: Lyrica 150Mg Capsule

What is being measured

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

  1. Part I : AUClast of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  2. Part I : Cmax of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  3. Part II : AUCτ,ss of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  4. Part II : Cmax,ss of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Secondary outcomes (13)

  1. Part I : AUCinf of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  2. Part I : Tmax of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  3. Part I : t1/2 of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  4. Part I : Vd/F of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  5. Part I : CL/F of Pregabalin

    Measured: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  6. Part II : Cmin,ss of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  7. Part II : AUClast,ss of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  8. Part II : Tmax,ss of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  9. Part II : t1/2 of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  10. Part II : CLss/F of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  11. Part II : Vdss/F of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  12. Part II : accumulation ratio(Cmax) of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

  13. Part II : accumulation ratio(AUCτ) of Pregabalin

    Measured: Pre-dose, 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours

Timeline

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

  1. First posted25 Aug 2017
  2. Study start14 Sep 2017
  3. Primary completion11 Oct 2017
  4. Study completion29 Mar 2018

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261427
Sponsor's protocol ID
YJ16-101
Status last verified
Jul 2019
First submitted
22 Aug 2017
Last updated
10 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lyrica 150Mg Capsule and YNP-1807 330Mg Tablet in people with Healthy, run by Yungjin 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 6 inclusion and 5 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 10 Jul 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?

Part I : AUClast of Pregabalin (time frame: 0,1,2,3,4,5,6,7,8,10,12,16,20,24,36 hours). The study lists 4 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 NCT03261427.

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 10 Jul 2019.

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