Bioequivalence Study of Cephalexin Suspension 125
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections, Respiratory Tract
Intervention: Cephalexin 125 mg/5ml (Drug); Cephalexin 125 mg/5ml (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The objective of this study was to confirm if two formulations of cephalexin suspension are
bioequivalent.
Test product was Ceporex® (125 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product
Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 20 ml of suspension.
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.
Clinical Details
Official title: Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparation of Cephalexin 125 mg/ 5 ml (Ceporex® GlaxoSmithKline México, S.A. de C.V. vs. Keflex®, Eli Lilly y Compañía de México, S.A. de C.V.) in Fasting Healthy Volunteers
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Primary outcome: Peak Plasma Concentration (CMAX) of cephalexinArea under the plasma concentration versus time curve (AUC) of cephalexin
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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) -
Exclusion Criteria:
Alteration of vital signs Not complying with inclusion criteria History of cardiovascular,
kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation),
neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic
disease. Those suffering from muscular trauma 21 days before the beginning of the study.
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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Locations and Contacts
Additional Information
Starting date: January 2011
Last updated: January 10, 2013
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