Bioequivalence Study of Cephalexin Tablets 1g

NCT01767584 | Completed Phase 1

• 1 other identifier: 116999
• 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 cephalexin tablets are bioequivalent. Test product was Ceporex® (1 g Cephalexin; GlaxoSmithKline) and reference product Keflex® (1 g Cephalexin; Eli Lilly). The single dosage was one tablet. 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 18-40 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

Keywords

Pharmacokinetics; Bioequivalence; Mexico; Cephalexin

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (CMAX) of cephalexin

  Pharmacokinetics

  0.0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 postdosage

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

  Pharmacokinetics

  0.0, 0.25, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 postdosage

Study Arms (2)

A (reference)/ B (test)

EXPERIMENTAL

initial administration of reference and cross-over to test

Drug: Cephalexin 1g tablets

B (test)/ A (reference)

EXPERIMENTAL

initial administration of test and cross-over to reference

Drug: Cephalexin 1g tablets

Interventions

Cephalexin 1g tablets DRUG

Reference product

Also known as: Keflex, KEFLEX® is a trademark of ELI LILLY

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.
• Healthy, between 18 and 40 years. Body Mass Index between 19 and 27 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) -

You may not qualify if:

• 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 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.
• Hospitalization for any cause in the seven months before the beginning of the study.
• Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. 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. Positive pregnancy test. 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Links

• Results for study 116999 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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: January 10, 2013
• First Posted: January 14, 2013
• Study Start: April 6, 2009
• Primary Completion: April 14, 2009
• Study Completion: April 14, 2009
• Last Updated: July 7, 2017

Record last verified: 2017-07