HealthyPhase 1NCT00864760
A Relative Bioavailability Study of Gabapentin 800 mg Tablets Under Fasting Conditions
A Phase 1 study testing Gabapentin 800 mg tablets, single dose (1 tablet) and NEURONTIN® 400 mg capsules, single dose (2 capsules) in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gabapentin 800 mg tablets, single dose (1 tablet) and NEURONTIN® 400 mg capsules, single dose (2 capsules)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Jun 1999
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Screening Demographics: All volunteers selected for this study will be healthy men 18 to 45 years of age, inclusive, at the time of dosing. The weight range will not exceed ± 15% for height and body frame as per Desirable Weights for Men• 1983 Metropolitan Height and Weight Table.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- The screening clinical laboratory procedures will include:
- HEMATOLOGY: hematocrit, hemoglobin, WBC count with differential, RBC count, platelet count
- CLINICAL CHEMISTRY: serum creatinine, BUN, glucose, AST(GOT), ALT(GPT), albumin, total bilirubin, total protein, and alkaline phosphatase
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- HIV antibody and hepatitis B surface antigen screen
- URINALYSIS: pH, albumin, sugar, acetone, bilirubin, occult blood and microscopic analysis
- URINE DRUG SCREEN: ethyl alcohol. amphetamines. barbiturates, benzodiazepines, cannabinoids. cocaine metabolites, opiates and phencyclidine.
Who cannot join
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence ofa clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the medical investigator).
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
- Volunteers with a history of allergic response(s) to gabapentin or related drugs.
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- Volunteers with a history of clinically significant allergies including drug allergies.
- Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the medical investigator.
- Volunteers who currently use tobacco products.
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
- Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will be advised not to donate blood for four weeks after completing the study.
- Volunteers who have donated plasma (e.g. plasmaphoresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
- Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
- Volunteers who report taking any systemic prescription medication in the 14 days prior to Period I dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis under fasting conditions.
Read the detailed description
Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover design under fasting conditions
Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets versus 400 mg Gabapentin Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- Gabapentin 800 mg tablets, single dose (1 tablet), NEURONTIN® 400 mg capsules, single dose (2 capsules)
- Keywords
- Bioequivalence, Gabapentin, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 800 mg tablets, single dose (1 tablet)Drug
A: Experimental Subjects received Purepac formulated products under fasting conditions
NEURONTIN® 400 mg capsules, single dose (2 capsules)Drug
Also called Gabapentin
B: Active comparator Subjects received Parke-Davis formulated products under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Gabapentin 800 mg tablets, single dose (1 tablet) Receives: Drug: Gabapentin 800 mg tablets, single dose (1 tablet) |
| B | Active comparator | NEURONTIN® 400 mg capsules, single dose (2 capsules) Receives: Drug: NEURONTIN® 400 mg capsules, single dose (2 capsules) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Extend of Absorption
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startJun 1999
- Primary completionJun 1999
- Study completionJun 1999
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James D. Carlson,, Pharm. D., Principal investigator, PRACS Institute, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864760
- Sponsor's protocol ID
- P99-228
- Status last verified
- Aug 2010
- First submitted
- 17 Mar 2009
- Last updated
- 17 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 800 mg Gabapentin Tablets Versus 400 mg Gabapentin Capsules Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT00864760
- Acronym / sponsor ID
- P99-228
- Conditions
- Healthy
- Keywords
- Bioequivalence, Gabapentin, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 1999
- Primary completion
- Jun 1999 (actual)
- Study completion
- Jun 1999 (actual)
- First posted
- 19 Mar 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 compare the relative bioavailability of 800 mg Gabapentin Tablets by Purepac Pharmaceutical Co. with that of 400 mg (2 x 400 mg) NEURONTIN® by Parke-Davis under fasting conditions.
Detailed description
Study Type: Interventional Study Design: Randomized, single-dose, two-way crossover design under fasting conditions
Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets versus 400 mg Gabapentin Capsules Under Fasting Conditions
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Gabapentin 800 mg tablets, single dose (1 tablet)Gabapentin 800 mg tablets, single dose (1 tablet) |
| B | Active comparator | Drug: NEURONTIN® 400 mg capsules, single dose (2 capsules)NEURONTIN® 400 mg capsules, single dose (2 capsules) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Screening Demographics: All volunteers selected for this study will be healthy men 18 to 45 years of age, inclusive, at the time of dosing. The weight range will not exceed ± 15% for height and body frame as per Desirable Weights for Men• 1983 Metropolitan Height and Weight Table.
- Screening Procedures: Each volunteer will complete the screening process within 28 days prior to Period I dosing. Consent documents for both the screening evaluation and HIV antibody determination will be reviewed, discussed, and signed by each potential participant before full implementation of screening procedures.
- Screening will include general observations, physical examination, demographics, medical and medication history, an electrocardiogram, sitting blood pressure and heart rate, respiratory rate and temperature. The physical examination will include, but may not be limited to, an evaluation of the cardiovascular, gastrointestinal, respiratory and central nervous systems.
- The screening clinical laboratory procedures will include:
Key exclusion criteria (14 listed)
- Volunteers with a recent history of drug or alcohol addiction or abuse.
- Volunteers with the presence ofa clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the medical investigator).
- Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
- Volunteers demonstrating a positive hepatitis B surface antigen screen or a reactive HIV antibody screen.
- Volunteers demonstrating a positive drug abuse screen when screened for this study.
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 |
|---|---|---|
| Gabapentin 800 mg tablets, single dose (1 tablet)A: Experimental Subjects received Purepac formulated products under fasting conditions | Drug | A |
| NEURONTIN® 400 mg capsules, single dose (2 capsules)Also: GabapentinB: Active comparator Subjects received Parke-Davis formulated products under fasting conditions | Drug | B |
Primary outcome
Rate and Extend of Absorption
Time frame: 72 hours
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 17 Aug 2010.
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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.
James D. Carlson,, Pharm. D. principal investigator
PRACS Institute, Ltd.
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 Gabapentin 800 mg tablets, single dose (1 tablet) and NEURONTIN® 400 mg capsules, single dose (2 capsules) in people with Healthy, run by Actavis 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 9 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 17 Aug 2010. 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?
Rate and Extend of Absorption (time frame: 72 hours). 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 17 Aug 2010.