Bioequivalence Study of 300 mg Gabapentin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01738893
First received: November 28, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

The objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent.

Test product was Darbetin® 300 mg (Laboratorios Dermatológicos Darier) and reference product Nerotin® 300 mg (Pfizer). One capsule was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 26 healthy volunteers, both genders, adults between 18-55 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Condition Intervention Phase
Epilepsy
Drug: Gabapentin 300 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Bioequivalence Study Between Two Medications for Administration of Oral Gabapentin in 300 mg Capsules in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Peak Plasma Concentration (CMAX) of drug gabapentin [ Time Frame: 0.0, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, and 24.0 postdosage ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Area under the plasma concentration versus time curve (AUC) of gabapentin [ Time Frame: 0.0, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, 10.0, 12.0, and 24.0 postdosage ] [ Designated as safety issue: No ]
    Pharmacokinetics


Enrollment: 26
Study Start Date: January 2011
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A (test)/ B (reference)
initial administration of test and cross-over to reference
Drug: Gabapentin 300 mg
Test product
Other Names:
  • Darbetin®
  • Laboratorios Dermatologicos Darier
Drug: Gabapentin 300 mg
Reference product
Other Names:
  • Nerotin®
  • Pfizer
Experimental: B (reference/ A (test)
initial administration of reference and cross-over to test
Drug: Gabapentin 300 mg
Test product
Other Names:
  • Darbetin®
  • Laboratorios Dermatologicos Darier
Drug: Gabapentin 300 mg
Reference product
Other Names:
  • Nerotin®
  • Pfizer

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Males 18-55 years. Healthy based on comprehensive medical history, lab tests, Chest x-ray, Electrocardiogram, negative tests for Hepatitis B and C, and HIV. Negative urine doping test. BMI 19-26.5 kg/m2. Lab test in normal range +/- 10%. Blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °C. Non-smoking at least for 10 hrs before study. Written informed consent. Women must be not pregnant, nor breast-feeding.

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Exclusion Criteria:

Hypersensitivity to study medication or other related drug. History of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition.

Requiring any drug interfering with minocycline pharmacokinetics. Exposed to inducers or inhibitors of hepatic enzymes. Intake of possible toxic drugs 30 days before study. Intake of any drug 14 days or 7 half-lives before study. Hospitalization or severe disease 60 days before study. Receiving investigational drug out of study center 30 days before study. Blood loss or blood donation =>450 ml 60 days before study. Recent history of drug abuse including alcohol. Intake of xanthine containing products 10 hrs before study. Intake of grapefruit juice or hot-spice 10 hrs before study.

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  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01738893

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01738893     History of Changes
Other Study ID Numbers: 116850
Study First Received: November 28, 2012
Last Updated: November 28, 2012
Health Authority: Mexico: Comision Federal para la Proteccion contra Riesgos Sanitarios (COFEPRIS)

Keywords provided by GlaxoSmithKline:
Gabapentin
Bioequivalence
Pharmacokinetics
Mexico

Additional relevant MeSH terms:
Gabapentin
Gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
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

ClinicalTrials.gov processed this record on September 16, 2014