HealthyPhase 1NCT02103686
Study for Comparing The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
A Phase 1 study testing Lyrica, Experimental drug and High fat meal in people with Healthy, run by IlDong Pharmaceutical Co Ltd.
Trial summary
The purpose of this study is to: 1. Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg * 2). 2. Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet. Read more about this study
- Who is it for?
- Ages 19 to 44 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lyrica, Experimental drug and High fat meal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jan 2013
- 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 44 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 19~44 aged healthy adult.
- someone tho has at least 50kg body weight and ideal body weight ±20%
Who cannot join
- someone has acute symptom at screening phase
- someone has any disease or symptoms which is clinically significant
- someone had been determined during healthy examination in screening period
- AST or ALT > 1.25 times than normal
- Total bilirubin > 1.5 times than normal
- someone who has a history of allergy, anaphylaxis, drug abuse or misuse.
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- someone who had enrolled to other clinical trial within the last 60 days.
- someone who had donated blood within the last 60 days.
- someone who can't take a meal derived from this trial.
- someone who has taken abnormal meals like which can affect to drug ADME
- someone who has taken other ETC drugs or oriental drugs within the last 14 days, Or OTC drugs within the last 7 days
- someone who has taken caffein continuously (coffee or green tea more than 5 cups per a day) or took caffein since 24hours before.
- someone who has taken alcohol more than 30g/day or smoked more than 10 piece of tobacco/day.
- someone who has galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
About this study
Official title: A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
The purpose of this study is to:
- Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg * 2).
- Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.
- Conditions
- Healthy
- Being tested
- Lyrica, Experimental drug, High fat meal, fasted
- Keywords
- Neuropathic pain, pregabalin
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LyricaDrug
Experimental drugDrug
sustained release formulation of pregabalin
High fat mealDietary supplement
fastedDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Immediate release capsule | Active comparator | Immediate release capsule treatment under fasted condition Receives: Drug: Lyrica; Dietary Supplement: fasted |
| sustained release tablet | Experimental | sustained release tablet treatment under fasted condition Receives: Drug: Experimental drug; Dietary Supplement: fasted |
| sustained release tablet (high fat meal) | Experimental | sustained release tablet under high fat meal condition. Receives: Drug: Experimental drug; Dietary Supplement: High fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUC of pregabalin
Measured: 0~36h
Secondary outcomes (1)
Safety evaluation
Measured: 0~24day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionJan 2013
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- IlDong Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02103686
- Sponsor's protocol ID
- ID-PRSD-1201
- Status last verified
- Sep 2012
- First submitted
- 18 Mar 2014
- Last updated
- 1 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, 3-way Crossover Clinical Trial to Compare The Pharmacokinetics of A Pregabalin Controlled Release Tablet 300mg With Immediate Release Formulation and to Assess the Effect of High Fat Diet in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02103686
- Acronym / sponsor ID
- ID-PRSD-1201
- Conditions
- Healthy
- Keywords
- Neuropathic pain, pregabalin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- IlDong Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Apr 2014 (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 study is to:
- Compare the pharmacokinetics profiles of pregabalin sustained release tablet (300mg) to immediate release capsule(150mg * 2).
- Evaluate the effectiveness of food to pharmacokinetics profile of Pregabalin sustained release tablet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immediate release capsule | Active comparator | Drug: Lyrica, Dietary Supplement: fastedImmediate release capsule treatment under fasted condition |
| sustained release tablet | Experimental | Drug: Experimental drug, Dietary Supplement: fastedsustained release tablet treatment under fasted condition |
| sustained release tablet (high fat meal) | Experimental | Drug: Experimental drug, Dietary Supplement: High fat mealsustained release tablet under high fat meal condition. |
Who may qualify
- Ages
- 19 to 44 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 19~44 aged healthy adult.
- someone tho has at least 50kg body weight and ideal body weight ±20%
Key exclusion criteria (14 listed)
- someone has acute symptom at screening phase
- someone has any disease or symptoms which is clinically significant
- someone had been determined during healthy examination in screening period
- AST or ALT > 1.25 times than normal
- Total bilirubin > 1.5 times than normal
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 |
|---|---|---|
| Lyrica | Drug | Immediate release capsule |
| Experimental drugsustained release formulation of pregabalin | Drug | sustained release tablet, sustained release tablet (high fat meal) |
| High fat meal | Dietary supplement | sustained release tablet (high fat meal) |
| fasted | Dietary supplement | Immediate release capsule, sustained release tablet |
Primary outcome
Cmax, AUC of pregabalin
Time frame: 0~36h
1 secondary outcome
Safety evaluation
Time frame: 0~24day
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 1 Sep 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lyrica, Experimental drug and High fat meal in people with Healthy, run by IlDong Pharmaceutical Co Ltd.
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 14 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 1 Sep 2014. 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, AUC of pregabalin (time frame: 0~36h). 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 1 Sep 2014.