HealthyPhase 1NCT00864305
A Relative Bioavailability Study of Gabapentin 400 mg Capsules Under Non-fasting Conditions
A Phase 1 study testing Gabapentin 400 mg capsules, NEURONTIN® 400 mg capsules and Gabapentin 400 mg capsules, single dose in people with Healthy, run by Actavis Inc. at 1 site in United States.
Trial summary
To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food 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 400 mg capsules, NEURONTIN® 400 mg capsules and Gabapentin 400 mg capsules, single dose
- 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 siteUnited States
- Study dates
- Dec 1997to Jan 1998
- 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
- All subjects selected for this study will be males 18 to 45 (inclusive) years of age. Weight range of the subjects shall be 135-246 pounds, with individual weight variation not more than 10% ± from normal for height and body frame (Metropolitan Life, 1983, Height, Weight, Body Chart).
- Each subject shall be given a general physical examination within 21 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
- At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
- Adequate blood and urine samples should be obtained within 21 days before beginning of the first period and at the end of the trial for clinical laboratory measurements. Clinical laboratory measurements will include the following:
- Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).
- Clinical Chemistry: creatinine, BUN, glucose, SGOT, SGPT, bilirubin, and alkaline phosphate Urine Analysis: pH, specific gravity, protein, glucose, ketones, bilirubin, occult blood, and cells.
- HTLV III Screen: (pre-study only) Hepatitis-B Surface Ag Screen: (pre-study only) Drugs of Abuse Screen: (pre-study only) Subjects will be selected if all above are normal.
Who cannot join
- Subjects with a history of chronic alcohol consumption, drug addition, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be restricted. If the clinical values are outside the range on testing, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
- Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
- All subjects will have urine samples assayed for the presence of drugs of abuse as a part of the clinical laboratory screening procedures. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
- Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to starting the study.
- Subjects who have taken any investigational drug within thirty (30) days prior to the start of the study will not be allowed to participate.
- Subjects who have been exposed to known hepatic enzyme inducting or inhibiting agents within thirty (30) days prior to dosing will not be allowed to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gateway Medical Research, Inc
Saint Charles, Missouri, 63301
About this study
To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food
Read the detailed description
Study Type: Interventional Study Design: Single dose, randomized, three-period, three-treatment, six-sequence crossover study under non-fasting conditions (test and reference) and fasting (test) conditions
Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg Capsules
Further study details as provided by Actavis Elizabeth LLC:
Primary Outcome Measures:
Rate and Extend of Absorption
- Conditions
- Healthy
- Being tested
- Gabapentin 400 mg capsules, NEURONTIN® 400 mg capsules, Gabapentin 400 mg capsules, single dose
- 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 400 mg capsulesDrug
Also called Gabapentin
A: Experimental Subjects received Purepac formulated products under fed conditions
NEURONTIN® 400 mg capsulesDrug
Also called Gabapentin
B: Active comparator Subjects received Parke-Davis's marketed product
Gabapentin 400 mg capsules, single doseDrug
Also called Gabapentin
C: Experimental Subjects received Purepac formulated products under fasting conditions
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Gabapentin 400 mg capsules Receives: Drug: Gabapentin 400 mg capsules; Drug: Gabapentin 400 mg capsules, single dose |
| B | Active comparator | Neurontin 400 mg capsules Receives: Drug: NEURONTIN® 400 mg 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 posted18 Mar 2009 (estimated)
- Study startDec 1997
- Primary completionJan 1998
- Study completionJan 1998
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actavis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Siler, M.D., Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864305
- Sponsor's protocol ID
- B-09237
- 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 Gabapentin 400 mg Capsules Under Non-fasting Conditions
- ClinicalTrials.gov ID
- NCT00864305
- Acronym / sponsor ID
- B-09237
- Conditions
- Healthy
- Keywords
- Bioequivalence, Gabapentin, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Actavis Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 1997
- Primary completion
- Jan 1998 (actual)
- Study completion
- Jan 1998 (actual)
- First posted
- 18 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.
To compare the relative bioavailability of gabapentin 400 mg capsules (Purepac) with that of NEURONTIN® 400 mg capsules (Parke-Davis) in healthy adult male subjects under non-fasting conditions, and to compare the differences in plasma levels after dosing the test formulation with and without food
Detailed description
Study Type: Interventional Study Design: Single dose, randomized, three-period, three-treatment, six-sequence crossover study under non-fasting conditions (test and reference) and fasting (test) conditions
Official Title: A relative Bioavailability Food Challenge Study of Gabapentin 400 mg Capsules
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 400 mg capsules, Drug: Gabapentin 400 mg capsules, single doseGabapentin 400 mg capsules |
| B | Active comparator | Drug: NEURONTIN® 400 mg capsulesNeurontin 400 mg capsules |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- All subjects selected for this study will be males 18 to 45 (inclusive) years of age. Weight range of the subjects shall be 135-246 pounds, with individual weight variation not more than 10% ± from normal for height and body frame (Metropolitan Life, 1983, Height, Weight, Body Chart).
- Each subject shall be given a general physical examination within 21 days of initiation of the study. Such examination includes, but is not limited to, blood pressure, general observations, and history.
- At the end of the study, the subjects will have an exit evaluation consisting of interim history, global evaluation, and clinical laboratory measurements.
- Adequate blood and urine samples should be obtained within 21 days before beginning of the first period and at the end of the trial for clinical laboratory measurements. Clinical laboratory measurements will include the following:
- Hematology: hemoglobin, hematocrit, red blood cell count, platelets, and white blood cell count (with differential).
Key exclusion criteria (8 listed)
- Subjects with a history of chronic alcohol consumption, drug addition, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
- Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be restricted. If the clinical values are outside the range on testing, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
- Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
- Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
- All subjects will have urine samples assayed for the presence of drugs of abuse as a part of the clinical laboratory screening procedures. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
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 400 mg capsulesAlso: GabapentinA: Experimental Subjects received Purepac formulated products under fed conditions | Drug | A |
| NEURONTIN® 400 mg capsulesAlso: GabapentinB: Active comparator Subjects received Parke-Davis's marketed product | Drug | B |
| Gabapentin 400 mg capsules, single doseAlso: GabapentinC: Experimental Subjects received Purepac formulated products under fasting conditions | Drug | A |
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.
Thomas Siler, M.D. principal investigator
Cetero Research, San Antonio
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 400 mg capsules, NEURONTIN® 400 mg capsules and Gabapentin 400 mg capsules, single dose 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 7 inclusion and 8 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.