ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 58 of 371 for:    under | North Dakota, United States

Bioequivalence Study of Gabapentin 800 mg Tablets Under Fed Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00778232
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Sponsor:
Information provided by:
Ranbaxy Inc.

Brief Summary:
This study compared the relative bioavailability (rate and extent of absorption) of Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited with that of Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd. Distributed by Parke-Davis, division of Warner-Lambert Co. following a single oral dose (1x800 mg tablet) in healthy adult volunteers under non-fasting conditions.

Condition or disease Intervention/treatment Phase
Healthy Drug: Gabapentin tablets 800 mg Not Applicable

Detailed Description:

A single oral dose of the test or the reference product was administered to 22 healthy adult human volunteers on two separate occasions under non-fasting conditions with at least a 7 day washout between the doses. Food and the fluid intake were controlled during each confinement period.

Twenty two (22) healthy adult human volunteers (12 males and 10 females) were enrolled in the study. All twenty two (22) subjects successfully completed the clinical portion of the study


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Relative Bioavailability Study of 800 mg Gabapentin Tablets Under Non-Fasting Conditions
Study Start Date : October 2002
Actual Primary Completion Date : November 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Gabapentin tablets 800 mg by Ranbaxy Laboratories Limited
Drug: Gabapentin tablets 800 mg
Active Comparator: 2
Neurontin ® 800 mg tablets of Parke Davis Pharmaceuticals Ltd
Drug: Gabapentin tablets 800 mg



Primary Outcome Measures :
  1. Bioequivalence


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. All volunteers selected for the study will be healthy men or women 18 years of age or older at the time of dosing
  2. The weight will no exceed ± 20% for the height and body frame as per desirable weight for adults - 1983 Metropolitan height and weight table
  3. If female and Of Child bearing 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 devices (IUD), or abstinence; or Is postmenopausal for at least 1 year; or Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Exclusion Criteria:

  1. volunteers with a recent history of drug or alcohol addiction or abuse
  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 demonstrating 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 a 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 clinically significant illness during the 4 weeks prior to period I dosing (as determined by the clinical investigators)
  11. Volunteers who are currently using 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00778232


Locations
United States, North Dakota
PRACS Institute Ltd.
Fargo, North Dakota, United States, 58104
Sponsors and Collaborators
Ranbaxy Laboratories Limited

Additional Information:
Responsible Party: Dr. Tausif Monif, Ranbaxy Research Labs
ClinicalTrials.gov Identifier: NCT00778232     History of Changes
Other Study ID Numbers: R01-826
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

Keywords provided by Ranbaxy Inc.:
Bioequivalence Gabapentin tablets 800 mg fed conditions

Additional relevant MeSH terms:
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents