HealthyPhase 1NCT01080612
A Study To Assess The Pharmacokinetics, Safety, And Tolerability Of A Pregabalin Controlled Release Formulation Administered Following Various Sized Caloric Meals As Compared To The Pregabalin Immediate Release Formulation
A Phase 1 study testing 300 mg pregabalin immediate release in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
Trial summary
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg… 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?
- 300 mg pregabalin immediate release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jun 2010
- 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.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release Formulation
The purpose of this study is to (1) evaluate the effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
Read the detailed description
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
- Conditions
- Healthy
- Being tested
- 330 mg pregabalin controlled release, 300 mg pregabalin immediate release
- Keywords
- pregabalin, pharmacokinetics, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
330 mg pregabalin controlled releaseDrug
A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
330 mg pregabalin controlled releaseDrug
A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
330 mg pregabalin controlled releaseDrug
A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
300 mg pregabalin immediate releaseDrug
A single dose of 300 mg immediate release capsule will be administered in the fasted state
| Study group | Role | What they receive |
|---|---|---|
| 330 mg pregabalin controlled release: 400 to 500 calories | Experimental | Not described Receives: Drug: 330 mg pregabalin controlled release |
| 330 mg pregabalin controlled release: 600 to 750 calories | Experimental | Not described Receives: Drug: 330 mg pregabalin controlled release |
| 330 mg pregabalin controlled release: 800 to 1000 calories | Experimental | Not described Receives: Drug: 330 mg pregabalin controlled release |
| 300 mg pregabalin immediate release | Other | Not described Receives: Drug: 300 mg pregabalin immediate release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
Measured: 3 days
Secondary outcomes (1)
Adverse events, vital signs, and clinical safety laboratories.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
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
- 24 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
- NCT01080612
- Sponsor's protocol ID
- A0081239
- Status last verified
- Jul 2010
- First submitted
- 26 Feb 2010
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
PubMed 25078976
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Randomized, Four-Way Crossover Study In Healthy Volunteers To Investigate The Pharmacokinetics Of Pregabalin Controlled Release Formulation Administered Following Various Caloric Intakes As Compared To The Immediate Release Formulation
- ClinicalTrials.gov ID
- NCT01080612
- Acronym / sponsor ID
- A0081239
- Conditions
- Healthy
- Keywords
- pregabalin, pharmacokinetics, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 Mar 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 effect of caloric intake on the pharmacokinetics of a single dose of a 330 mg pregabalin controlled release tablet relative to a 300 mg pregabalin immediate release capsule administered fasted and (2) determine the safety and tolerability of a single dose of a 330 mg pregabalin controlled release formulation administered following various sized caloric meals and the 300 mg pregabalin immediate release capsule administered fasted.
Detailed description
To assess the single dose pharmacokinetics, safety, and tolerability of pregabalin controlled release formulation following various sized caloric meals relative to the immediate release formulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 330 mg pregabalin controlled release: 400 to 500 calories | Experimental | Drug: 330 mg pregabalin controlled release |
| 330 mg pregabalin controlled release: 600 to 750 calories | Experimental | Drug: 330 mg pregabalin controlled release |
| 330 mg pregabalin controlled release: 800 to 1000 calories | Experimental | Drug: 330 mg pregabalin controlled release |
| 300 mg pregabalin immediate release | Other | Drug: 300 mg pregabalin immediate release |
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 |
|---|---|---|
| 330 mg pregabalin controlled releaseA single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal | Drug | 330 mg pregabalin controlled release: 400 to 500 calories |
| 330 mg pregabalin controlled releaseA single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal | Drug | 330 mg pregabalin controlled release: 600 to 750 calories |
| 330 mg pregabalin controlled releaseA single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal | Drug | 330 mg pregabalin controlled release: 800 to 1000 calories |
| 300 mg pregabalin immediate releaseA single dose of 300 mg immediate release capsule will be administered in the fasted state | Drug | 300 mg pregabalin immediate release |
Primary outcome
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf)
Time frame: 3 days
1 secondary outcome
Adverse events, vital signs, and clinical safety laboratories.
Time frame: 3 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 29 Jan 2021.
- Derived from this study: PubMed 25078976Chew ML, Plotka A, Alvey CW, Pitman VW, Alebic-Kolbah T, Scavone JM, Bockbrader HN. Pharmacokinetics of pregabalin controlled-release in healthy volunteers: effect of food in five single-dose, randomized, clinical pharmacology studies. Clin Drug Investig. 2014 Sep;34(9):617-26. doi: 10.1007/s40261-014-0211-4.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 300 mg pregabalin immediate release in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in United States.
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 29 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 United States. 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?
Pregabalin area under the curve (AUC) from time of study drug administration to the last quantifiable plasma concentration (AUClast) and to infinity (AUCinf) (time frame: 3 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 NCT01080612, 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 29 Jan 2021.