Peripheral Nueropathy PainPhase 1NCT02783183

A Open-label, Randomized, Crossover Study to Assess PK of Pregabalin

A Phase 1 study testing YHD1119 and Lyrica in people with Peripheral Nueropathy Pain, run by Yuhan Corporation.

Completed

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

Trial summary

The purpose of this trial to compare the pharmacokinetic characteristics of YHD1119(Pregabalin 300mg) and Lyrica capsule(Pregabalin 150mg). YHD1119 is controlled release formulation which is made by Yuhan Corporation. Read more about this study

Who is it for?: Ages 19 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Peripheral Nueropathy Pain
What is being tested?: YHD1119 and Lyrica
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: No sites listed yet
Study dates: Jun 2016to Nov 2016
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 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

19~50 years old, healthy male volunteers
>55Kg(Body weight) and 18.5<BMI<28

Who cannot join

AST or ALT > 3 * Upper normal range (Lab)
Total bilirubin > 2.0 mg/dl
Systolic BP >140 OR <90, Diastolic BP >100 OR <60

About this study

Official title: A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers

Conditions: Peripheral Nueropathy Pain
Being tested: YHD1119, Lyrica

What participants receive

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

YHD1119Drug
Also called Pregabalin 300mg
2 by 2
LyricaDrug
Also called Pregabalin 150mg
2 by 2

Study groups in NCT02783183
Study group	Role	What they receive
YHD1119	Experimental	Pregabalin 300mg Receives: Drug: YHD1119; Drug: Lyrica
Lyrica	Active comparator	Pregabalin 150mg Receives: Drug: YHD1119; Drug: Lyrica

What is being measured

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

Cmax,ss
Measured: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCtau
Measured: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Secondary outcomes (3)

AUClast,ss
Measured: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCinf,ss
Measured: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Tmax,ss
Measured: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Timeline

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

Jun 2016Nov 2016

First posted26 May 2016 (estimated)
Study startJun 2016
Primary completionAug 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Peripheral Nueropathy PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02783183
Sponsor's protocol ID: YHD1119-103
Status last verified: Nov 2016
First submitted: 23 May 2016
Last updated: 16 Jan 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.
PubMed 34256964

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Open-label, Radomized, Crossover Clinical Trial to Assess the Pharmacokinetics of Pregabalin CR After Multiple Dosing as Compared to Pregabalin IR in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT02783183
Acronym / sponsor ID: YHD1119-103
Conditions: Peripheral Nueropathy Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Yuhan CorporationIndustry (pharma, biotech, devices)
Study start: Jun 2016
Primary completion: Aug 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 26 May 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
YHD1119	Experimental	Drug: YHD1119, Drug: LyricaPregabalin 300mg
Lyrica	Active comparator	Drug: YHD1119, Drug: LyricaPregabalin 150mg

Who may qualify

Ages: 19 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

19~50 years old, healthy male volunteers
>55Kg(Body weight) and 18.5<BMI<28

Key exclusion criteria (3 listed)

AST or ALT > 3 * Upper normal range (Lab)
Total bilirubin > 2.0 mg/dl
Systolic BP >140 OR <90, Diastolic BP >100 OR <60

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
YHD1119Also: Pregabalin 300mg2 by 2	Drug	Lyrica, YHD1119
LyricaAlso: Pregabalin 150mg2 by 2	Drug	Lyrica, YHD1119

Primary outcome

Cmax,ss
Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCtau
Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

3 secondary outcomes

AUClast,ss
Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
AUCinf,ss
Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours
Tmax,ss
Time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
Derived from this study: PubMed 34256964Moon SJ, Jeon JY, Lim Y, An T, Jang SB, Kim S, Na WS, Lee SY, Kim MG. Pharmacokinetics of a New, Once-Daily, Sustained-release Pregabalin Tablet in Healthy Male Volunteers. Clin Ther. 2021 Aug;43(8):1381-1391.e1. doi: 10.1016/j.clinthera.2021.06.010. Epub 2021 Jul 11.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing YHD1119 and Lyrica in people with Peripheral Nueropathy Pain, run by Yuhan Corporation.

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 2 inclusion and 3 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Cmax,ss (time frame: 0.33,0.67,1,2,4,8,12,12.33,12.67,13,14,16,20,24,36 hours). 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 NCT02783183, 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 16 Jan 2019; AzTrials last refreshed its copy on 30 Oct 2026.