HealthyPhase 1NCT01257516
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
A Phase 1 study testing Pregabalin immediate release, 300 mg in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Belgium.
Trial summary
The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pregabalin immediate release, 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2011to Mar 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or females
- Between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Who cannot join
- Illicit drug use
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of 660 Mg (2 X 330 Mg Tablets) Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 300 Mg Of The Immediate Release Formulation Administered Twice Daily
The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.
Read the detailed description
Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule
- Conditions
- Healthy
- Being tested
- Pregabalin immediate release, 300 mg, Pregabalin controlled release, 330 mg
- Keywords
- pregabalin, pharmacokinetics, bioavailability, bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin immediate release, 300 mgDrug
300 mg immediate release capsule administered twice daily for four days
Pregabalin controlled release, 330 mgDrug
Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin immediate release, 300 mg | Other | Reference Treatment Receives: Drug: Pregabalin immediate release, 300 mg |
| Pregabalin controlled release, 330 mg | Experimental | Not described Receives: Drug: Pregabalin controlled release, 330 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg)
Measured: 5 days
Secondary outcomes (1)
Safety endpoints include evaluation of adverse events
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
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 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257516
- Sponsor's protocol ID
- A0081216
- Status last verified
- Mar 2011
- First submitted
- 8 Dec 2010
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.
PubMed 25078977
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-Dose, Randomized, 2-Way Crossover Study In Healthy Volunteers To Determine The Steady-State Pharmacokinetics Of 660 Mg (2 X 330 Mg Tablets) Pregabalin Controlled Release Formulation Administered Following An Evening Meal Relative To The 300 Mg Of The Immediate Release Formulation Administered Twice Daily
- ClinicalTrials.gov ID
- NCT01257516
- Acronym / sponsor ID
- A0081216
- Conditions
- Healthy
- Keywords
- pregabalin, pharmacokinetics, bioavailability, bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Dec 2010 (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 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule.
Detailed description
Evaluate the absorption, pharmacokinetics, safety/tolerability of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of pregabalin immediate release capsule
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin immediate release, 300 mg | Other | Drug: Pregabalin immediate release, 300 mgReference Treatment |
| Pregabalin controlled release, 330 mg | Experimental | Drug: Pregabalin controlled release, 330 mg |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male or females
- Between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
Key exclusion criteria (3 listed)
- Illicit drug use
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
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 |
|---|---|---|
| Pregabalin immediate release, 300 mg300 mg immediate release capsule administered twice daily for four days | Drug | Pregabalin immediate release, 300 mg |
| Pregabalin controlled release, 330 mgTwo tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days | Drug | Pregabalin controlled release, 330 mg |
Primary outcome
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg)
Time frame: 5 days
1 secondary outcome
Safety endpoints include evaluation of adverse events
Time frame: 5 days
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 Jan 2021.
- Derived from this study: PubMed 25078977Chew ML, Alvey CW, Plotka A, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pregabalin controlled-release pharmacokinetics in healthy volunteers: analysis of four multiple-dose randomized clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):627-37. doi: 10.1007/s40261-014-0221-2.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 immediate release, 300 mg in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Belgium.
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 3 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 Jan 2021. 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 Belgium. 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?
Area under the curve at steady-state over a 24 hour period (AUC24)for assessment of equivalence between 330 mg CR (two tablets administered concurrently for a total 660 mg dose) and 300 mg IR capsule given 2times daily (total daily dose 600 mg) (time frame: 5 days). 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 NCT01257516, 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 22 Jan 2021.