Trials Sponsors Conditions Drugs Pricing

Conditions

Anti-Infective Agents

Outcome Measures

Primary Outcomes (2)

Least square estimator of average maximum plasmatic concentration (log transformed)
After two months
Least square estimator of area under the pharmacokinetic curve (log transformed)
After two months

Secondary Outcomes (5)

Time at which maximum concentration is reached
After two months
Area under the pharmacokinetic curve from time=0 to last blood sample
After two months
Clearance constant of plasmatic concentration of study drug
After two months
Half life of plasmatic concentration of study drug
After two months
Adverse events collection
Up to 6 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Cephalexin suspension (Optocef, BAYO5448)

Arm 2

ACTIVE COMPARATOR

Drug: Cephalexin suspension (Keflex)

Interventions

Cephalexin suspension (Optocef, BAYO5448)Drug

Single dose of 500 mg / 10 mL

Arm 1

Cephalexin suspension (Keflex)Drug

Single dose of 500 mg / 20 mL

Arm 2

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male or female volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis

You may not qualify if:

Sponsors & Collaborators

Corporación Bonima S.A. de C.V.
Industrycollaborator
Bayer
Industrylead

Study Sites (1)

Morelia, Michoacán, 58256, Mexico

MeSH Terms

Interventions

Cephalexin

Intervention Hierarchy (Ancestors)

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

Study Officials

Bayer Study Director
Bayer
STUDY DIRECTOR

Enrollment

26 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 22, 2010

First Posted

February 23, 2010

Study Start

September 2009

Date type not reported

This date has not been verified as actual or estimated.

Cross-over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (5)

Study Arms (2)

Arm 1

Arm 2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations