HealthyNCT00778401
Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions
A study testing Gabapentin tablets 800 mg in people with Healthy, run by Ranbaxy Laboratories Limited at 1 site in United States.
Trial summary
This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Gabapentin tablets 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Dec 2002
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing.
- The weight range will not exceed ± 20 % for height and body frame as per desirable weights for adult - 1983 Metropolitan Height and Weight Table
- If female and:
- Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or Is postmenopausal for at least 1 year; or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Who cannot join
- Volunteers with a recent history of drug or alcohol addiction or abuse
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system (s) or psychiatric disease (as determined by the clinical investigators)
- 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 demonstrated 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
- Female volunteers demonstrating a positive pregnancy screen
Show all 16Show fewer
- Female volunteers who are currently breast feeding
- Volunteers with history of allergic response(s) to Gabapentin or related drugs
- Volunteers with a history of clinically significant allergies including drug allergies
- Volunteers with a history of clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
- Volunteers who currently use tobacco products
- Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to period I dosing
- Volunteers who report donating greater than 150 mL of the 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 (eg. Plasmapheresis) 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 Under Fasting Condition
This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.
Read the detailed description
A single oral dose of the test or reference product was administered to the volunteers on two separate occasions under fasting conditions with at least a 7 day washout between doses. Food and fluid intake were controlled during each confinement period.
A total of twenty eight (28) healthy subjects (21 males and 7 females) were enrolled in the study of which twenty seven (27) subjects completed the study.
- Conditions
- Healthy
- Being tested
- Gabapentin tablets 800 mg
- Keywords
- Bioequivalence Gabapentin tablets 800 mg fasting conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin tablets 800 mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited Receives: Drug: Gabapentin tablets 800 mg |
| 2 | Active comparator | Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. Receives: Drug: Gabapentin tablets 800 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioequivalence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2008 (estimated)
- Study startOct 2002
- Primary completionOct 2002
- Study completionDec 2002
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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ranbaxy Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00778401
- Sponsor's protocol ID
- R01-825
- Status last verified
- Oct 2008
- First submitted
- 22 Oct 2008
- Last updated
- 23 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Fasting Condition
- ClinicalTrials.gov ID
- NCT00778401
- Acronym / sponsor ID
- R01-825
- Conditions
- Healthy
- Keywords
- Bioequivalence Gabapentin tablets 800 mg fasting conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ranbaxy Laboratories LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Oct 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 23 Oct 2008 (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.
This study compared the relative bioavailability (rate and extent of absorption) of the test Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited to the reference Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd., distributed by Parke Davis, division of Warner-Lambert Co. in 28 healthy, adult subjects (21 males and 7 females) under fasting conditions using randomized, two-way crossover design.
Detailed description
A single oral dose of the test or reference product was administered to the volunteers on two separate occasions under fasting conditions with at least a 7 day washout between doses. Food and fluid intake were controlled during each confinement period.
A total of twenty eight (28) healthy subjects (21 males and 7 females) were enrolled in the study of which twenty seven (27) subjects completed the study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Gabapentin tablets 800 mgGabapentin tablets 800 mg by Ranbaxy Laboratories Limited |
| 2 | Active comparator | Drug: Gabapentin tablets 800 mgNeurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All volunteers selected for this study will be healthy men or women 18 years of age or older at the time of dosing.
- The weight range will not exceed ± 20 % for height and body frame as per desirable weights for adult - 1983 Metropolitan Height and Weight Table
- If female and:
- Of childbearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator (s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or Is postmenopausal for at least 1 year; or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)
Key exclusion criteria (16 listed)
- Volunteers with a recent history of drug or alcohol addiction or abuse
- Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system (s) or psychiatric disease (as determined by the clinical investigators)
- 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 demonstrated 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 tablets 800 mg | Drug | 1, 2 |
Primary outcome
Bioequivalence
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 23 Oct 2008.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gabapentin tablets 800 mg in people with Healthy, run by Ranbaxy Laboratories Limited 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 4 inclusion and 16 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 23 Oct 2008. 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.
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?
Bioequivalence. 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 23 Oct 2008.