HealthyPhase 1NCT01420913
Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
A Phase 1 study testing Pregabalin in people with Healthy, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule. YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation. Primary endpoints are C max,ss and AUC tau. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pregabalin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Aug 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20~45 years old, healthy adult male subject
- >55 Kg(Body weight) and < ideal body weight ± 20%
Who cannot join
- AST or ALT > 1.25 * Upper normal range (Lab)
- Total bilirubin > 1.5 * Upper normal range
- Systolic BP >140 OR <100, Diastolic BP >90 OR <65
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.
YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.
Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2
- Conditions
- Healthy
- Being tested
- Pregabalin
- Keywords
- To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PregabalinDrug
Pregabalin 300mg a day
| Study group | Role | What they receive |
|---|---|---|
| Lyrica capsule(Pregabalin 150mg) | Active comparator | Not described Receives: Drug: Pregabalin |
| YHD1119 A(Pregabalin SR 300mg) | Experimental | Not described Receives: Drug: Pregabalin |
| YHD1119 B(Pregabalin SR 300mg) | Experimental | Not described Receives: Drug: Pregabalin |
| YHD1119 C(Pregabalin SR 300mg) | Experimental | Not described Receives: Drug: Pregabalin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax,ss
Measured: 36 hr
AUCtau
Measured: 36 hr
Safety monitoring
Laboratory findings Adverse event
Measured: 14 days
Secondary outcomes (4)
AUClast AUCinfinity Tmax,ss t1/2
Measured: 36 hour
AUCinfinity
Measured: 36 hr
Tmax,ss
Measured: 36 hr
t 1/2
Measured: 36 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420913
- Sponsor's protocol ID
- YCD207
- Status last verified
- Aug 2011
- First submitted
- 17 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized,Open-label,Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01420913
- Acronym / sponsor ID
- YCD207
- Conditions
- Healthy
- Keywords
- To evaluate the pharmacokinetic characteristics of Lyrica, YHD1119 A,B,C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Aug 2011 (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.
The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.
YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.
Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lyrica capsule(Pregabalin 150mg) | Active comparator | Drug: Pregabalin |
| YHD1119 A(Pregabalin SR 300mg) | Experimental | Drug: Pregabalin |
| YHD1119 B(Pregabalin SR 300mg) | Experimental | Drug: Pregabalin |
| YHD1119 C(Pregabalin SR 300mg) | Experimental | Drug: Pregabalin |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20~45 years old, healthy adult male subject
- >55 Kg(Body weight) and < ideal body weight ± 20%
Key exclusion criteria (3 listed)
- AST or ALT > 1.25 * Upper normal range (Lab)
- Total bilirubin > 1.5 * Upper normal range
- Systolic BP >140 OR <100, Diastolic BP >90 OR <65
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 |
|---|---|---|
| PregabalinPregabalin 300mg a day | Drug | Lyrica capsule(Pregabalin 150mg), YHD1119 A(Pregabalin SR 300mg), YHD1119 B(Pregabalin SR 300mg), YHD1119 C(Pregabalin SR 300mg) |
Primary outcome
Cmax,ss
Time frame: 36 hr
AUCtau
Time frame: 36 hr
Safety monitoring
Time frame: 14 days
Laboratory findings Adverse event
4 secondary outcomes
AUClast AUCinfinity Tmax,ss t1/2
Time frame: 36 hour
AUCinfinity
Time frame: 36 hr
Tmax,ss
Time frame: 36 hr
t 1/2
Time frame: 36 hr
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 22 Aug 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregabalin in people with Healthy, run by Yuhan Corporation 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 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 22 Aug 2011. 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?
Cmax,ss (time frame: 36 hr). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2011.