Bioequivalence Study of Cephalexin Suspension 250

NCT ID: NCT01767571

Last Updated: 2017-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-30
• Study Completion Date: 2011-02-08

Brief Summary

The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent.

Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for Ceporex and 20 ml of suspension for Keflex® .

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 28 healthy volunteers, both genders, adults between 18-50 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

Infections, Respiratory Tract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

A(reference)/B(test)

initial administration of reference and cross-over to test

Group Type: EXPERIMENTAL

Cephalexin 125 mg/5ml

Intervention Type: DRUG

Reference product 20 ml

Cephalexin 250mg/5ml

Intervention Type: DRUG

Test product 10 ml

B(test)/A(reference)

initial administration of test and cross-over to reference

Group Type: EXPERIMENTAL

Cephalexin 125 mg/5ml

Intervention Type: DRUG

Reference product 20 ml

Cephalexin 250mg/5ml

Intervention Type: DRUG

Test product 10 ml

Interventions

Cephalexin 125 mg/5ml

Reference product 20 ml

Intervention Type: DRUG

Cephalexin 250mg/5ml

Test product 10 ml

Intervention Type: DRUG

Other Intervention Names

Keflex® suspension ELI LILLY Y COMPAÑIA DE MEXICO SA de CV; Ceporex® suspension GLAXOSMITHKLINE MEXICO SA de CV

Eligibility Criteria

Inclusion Criteria

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 7 half-lives previous to the beginning of the study.

Hospitalization for any cause in the two months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any medication, food or substance. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss => 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Positive antidoping or pregnancy test Breast-feeding. Females on hormonal treatment.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

116995

Identifier Type: -

Identifier Source: org_study_id