HealthyPhase 1NCT01009541
An Investigation of the Absorption and Pharmacokinetics of Multiple Doses of Three Controlled Release Pregabalin Tablets as Compared to Multiple Doses of the Immediate Release Pregabalin Capsule
A Phase 1 study testing Pregabalin immediate release, 150 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 three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared… 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, 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2009to Dec 2009
- 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, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate Release Formulation
The purpose of this study is to 1) evaluate the extent of absorption of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
- Conditions
- Healthy
- Being tested
- Pregabalin controlled release, 82.5 mg, Pregabalin controlled release, 165 mg, Pregabalin controlled release, 330 mg, Pregabalin immediate release, 150 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 controlled release, 82.5 mgDrug
82.5 mg controlled release tablet administered once daily for three days.
Pregabalin controlled release, 165 mgDrug
165 mg controlled release tablet administered once daily for three days.
Pregabalin controlled release, 330 mgDrug
330 mg controlled release tablet administered once daily for three days.
Pregabalin immediate release, 150 mgDrug
150 mg immediate release capsules administered every 12 hours for three days
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin controlled release, 82.5 mg | Experimental | Not described Receives: Drug: Pregabalin controlled release, 82.5 mg |
| Pregabalin controlled release, 165 mg | Experimental | Not described Receives: Drug: Pregabalin controlled release, 165 mg |
| Pregabalin controlled release, 330 mg | Experimental | Not described Receives: Drug: Pregabalin controlled release, 330 mg |
| Pregabalin immediate release, 150 mg | Other | Reference Treatment Receives: Drug: Pregabalin immediate release, 150 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 for a dosing interval (AUCτ), Dose-adjusted AUCτ
Measured: 5 days
Minimum plasma concentration at steady-state within a dosing interval (Cmin)
Measured: 5 days
Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
Measured: 5 days
The average plasma concentration at steady-state (Cav), half-life
Measured: 5 days
Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)
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 posted6 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT01009541
- Sponsor's protocol ID
- A0081225
- Status last verified
- Dec 2009
- First submitted
- 5 Nov 2009
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
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, Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Three Dose Strengths Of Pregabalin Controlled Release Formulations Administered Following An Evening Meal As Compared To The Immediate Release Formulation
- ClinicalTrials.gov ID
- NCT01009541
- Acronym / sponsor ID
- A0081225
- Conditions
- Healthy
- Keywords
- pregabalin pharmacokinetics bioavailability bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 6 Nov 2009 (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 three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the pharmacokinetics of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of pregabalin immediate release capsule and 3) evaluate the safety and tolerability of multiple doses of three pregabalin controlled release tablets as compared to multiple doses of the pregabalin immediate release capsule.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pregabalin controlled release, 82.5 mg | Experimental | Drug: Pregabalin controlled release, 82.5 mg |
| Pregabalin controlled release, 165 mg | Experimental | Drug: Pregabalin controlled release, 165 mg |
| Pregabalin controlled release, 330 mg | Experimental | Drug: Pregabalin controlled release, 330 mg |
| Pregabalin immediate release, 150 mg | Other | Drug: Pregabalin immediate release, 150 mgReference Treatment |
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 controlled release, 82.5 mg82.5 mg controlled release tablet administered once daily for three days. | Drug | Pregabalin controlled release, 82.5 mg |
| Pregabalin controlled release, 165 mg165 mg controlled release tablet administered once daily for three days. | Drug | Pregabalin controlled release, 165 mg |
| Pregabalin controlled release, 330 mg330 mg controlled release tablet administered once daily for three days. | Drug | Pregabalin controlled release, 330 mg |
| Pregabalin immediate release, 150 mg150 mg immediate release capsules administered every 12 hours for three days | Drug | Pregabalin immediate release, 150 mg |
Primary outcome
Area under the curve at steady-state for a dosing interval (AUCτ), Dose-adjusted AUCτ
Time frame: 5 days
Minimum plasma concentration at steady-state within a dosing interval (Cmin)
Time frame: 5 days
Maximum plasma concentration at steady-state (Cmax), time of Cmax at steady-state (tmax)
Time frame: 5 days
The average plasma concentration at steady-state (Cav), half-life
Time frame: 5 days
Peak:trough ratio at steady-state (PTR), peak to trough fluctuation at steady-state (PTF), and peak:trough swing at steady-state (PTS)
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.
- 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, 150 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 for a dosing interval (AUCτ), Dose-adjusted AUCτ (time frame: 5 days). The study lists 5 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 Jan 2021.