Bioequivalence Study of 300 mg Gabapentin

NCT01738893 | Completed Phase 1

• 1 other identifier: 116850
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Epilepsy

Keywords

Gabapentin; Bioequivalence; Pharmacokinetics; Mexico

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (CMAX) of drug gabapentin

  Pharmacokinetics

  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

• Area under the plasma concentration versus time curve (AUC) of gabapentin

  Pharmacokinetics

  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

Study Arms (2)

A (test)/ B (reference)

EXPERIMENTAL

initial administration of test and cross-over to reference

Drug: Gabapentin 300 mg

B (reference/ A (test)

EXPERIMENTAL

initial administration of reference and cross-over to test

Drug: Gabapentin 300 mg

Interventions

Gabapentin 300 mg DRUG

Test product

Also known as: Darbetin®, Laboratorios Dermatologicos Darier

A (test)/ B (reference); B (reference/ A (test)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• Results for study 116850 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Epilepsy

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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 Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: November 30, 2012
• Study Start: January 14, 2011
• Primary Completion: January 22, 2011
• Study Completion: January 22, 2011
• Last Updated: June 20, 2017

Record last verified: 2017-06