Bioequivalence Study of 300 mg Gabapentin

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: Gabapentin 300 mg

• Registration Number: NCT01738893
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-14
• Primary Completion: 2011-01-22
• Study Completion: 2011-01-22
• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2012-11-28
• Study First Posted: 2012-11-30
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A (test)/ B (reference)	Gabapentin 300 mg	initial administration of test and cross-over to reference
B (reference/ A (test)	Gabapentin 300 mg	initial administration of reference and cross-over to test

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (CMAX) of drug gabapentin	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	Pharmacokinetics
Area under the plasma concentration versus time curve (AUC) of gabapentin	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	Pharmacokinetics