NCT01767532

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2011

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2013

Completed
Last Updated

June 22, 2017

Status Verified

June 1, 2017

Enrollment Period

9 days

First QC Date

January 10, 2013

Last Update Submit

June 21, 2017

Conditions

Infections, Respiratory Tract

Keywords

CephalexinRespiratory infectionsMexicoBioequivalence

Outcome Measures

Primary Outcomes (2)

  • Peak Plasma Concentration (CMAX) of cephalexin

    Pharmacokinetics

    0.0, 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 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, 0.083, 0.167, 0.333, 0.5, 0.75, 1.0, 1.25, 1.5, 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 125 mg/5ml

B(test)/A(reference)

EXPERIMENTAL

initial administration of test and cross-over to reference

Drug: Cephalexin 125 mg/5ml

Interventions

Cephalexin 125 mg/5mlDRUG

Reference product 20 ml

Also known as: Keflex® suspension ELI LILLY Y COMPAÑIA DE MEXICO SA de CV
A(reference)/B(test)B(test)/A(reference)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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) -

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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Cephalexin

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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

January 30, 2011

Primary Completion

February 8, 2011

Study Completion

February 8, 2011

Last Updated

June 22, 2017

Record last verified: 2017-06