Bioequivalence Study of Gabapentin 800 mg Tablets Under Fasting Conditions
NCT ID: NCT00778401
Last Updated: 2008-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2002-10-31
2002-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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1
Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited
Gabapentin tablets 800 mg
2
Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd.
Gabapentin tablets 800 mg
Interventions
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Gabapentin tablets 800 mg
Eligibility Criteria
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Inclusion Criteria
2. The weight range will not exceed ± 20 % for height and body frame as per desirable weights for adult - 1983 Metropolitan Height and Weight Table
3. 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)
Exclusion Criteria
2. 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)
3. Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant
4. Volunteers demonstrated a positive hepatitis B surface antigen screen or a reactive HIV antibody screen
5. Volunteers demonstrating a positive drug abuse screen when screened for this study
6. Female volunteers demonstrating a positive pregnancy screen
7. Female volunteers who are currently breast feeding
8. Volunteers with history of allergic response(s) to Gabapentin or related drugs
9. Volunteers with a history of clinically significant allergies including drug allergies
10. Volunteers with a history of clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
11. Volunteers who currently use tobacco products
12. Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 28 days prior to period I dosing
13. 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
14. 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
15. Volunteers who report receiving any investigational drug within 30 days prior to period I dosing
16. Volunteers who report taking any systemic prescription medication in the 14 days prior to period I dosing.
18 Years
ALL
Yes
Sponsors
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Ranbaxy Laboratories Limited
INDUSTRY
Responsible Party
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Ranbaxy Research Labs
Locations
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PRACS Institute Ltd.
Fargo, North Dakota, United States
Countries
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Related Links
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Related Info
Related Info
Related Info
Other Identifiers
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R01-825
Identifier Type: -
Identifier Source: org_study_id