Bioequivalence Study of Gabapentin 400 mg Capsules Under Fasting Conditions

NCT00778271 | Completed DMC

• 1 other identifier: AA01819
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to compare the single-dose relative bioavailability of Ranbaxy and Parke-Davis (Neurontin®) 400 mg Gabapentin, following administration of a 400 mg dose under fasting conditions

Conditions

Healthy

Keywords

Bioequivalence gabapentin 400mg capsules fasting conditions

Outcome Measures

Primary Outcomes (1)

• Bioequivalence

Study Arms (2)

1

EXPERIMENTAL

Gabapentin 400mg capsules

Drug: Gabapentin 400mg capsules

2

ACTIVE COMPARATOR

Neurontin® 400 mg capsules

Drug: Gabapentin 400mg capsules

Interventions

Gabapentin 400mg capsules DRUG

1; 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult male or female volunteers, 18-55 years of age
• Weighing at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983)
• Medically healthy subjects with clinically normal laboratory profiles
• Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the study and throughout the study or be using one of the following acceptable birth control methods:
• surgically sterile (bilateral tubal ligation, hysterectomy bilateral oophorectomy) 6 months minimum;
• IUD in place for at least 3 months;
• barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the start of the study and throughout the study;
• surgical sterilization of the partner (vasectomy for 6 months minimum); OR
• hormonal contraceptives for at least 3 months prior to the start of the study.
• Other birth control methods may be deemed acceptable. Postmenopausal women with amenorrhea for at least 2 years will be eligible.
• Voluntarily consent to participate in the study

You may not qualify if:

• Subject candidates must not be enrolled in the study if they meet any of the following criteria:
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
• In addition, history or presence of:
• alcoholism or drug abuse within the past 2 years; OR
• hypersensitivity or idiosyncratic reaction to antibiotics, especially penicillins, cephalosporins and amoxicillin and/or clavulanic acid.
• Female subjects who are pregnant or lactating
• Subjects who have been on an abnormal diet (for whatever reason) during the 30 days prior to the first dose
• Subjects who, through completion of the study, would have donated in excess of:
• mL of blood in 14 days, or
• mL of blood in 14 days (unless approved by the Principal Investigator),
• mL of blood in 90 days
• mL of blood in 120 days
• mL of blood in 180 days
• mL of blood in 270 days
• mL of blood in I year f) Subjects who have participated in another clinical trial within 28 days prior to the first dose

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

MDS Pharma Services

Saint-Laurent, Quebec, Canada

Location

Related Links

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MeSH Terms

Interventions

Gabapentin

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 22, 2008
• First Posted: October 23, 2008
• Study Start: September 1, 2002
• Primary Completion: October 1, 2002
• Study Completion: December 1, 2002
• Last Updated: October 23, 2008

Record last verified: 2008-10

Locations

CA (1)