Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: fexofenadine

• Registration Number: NCT01767272
• Lead Sponsor: Damanhour University

Brief Summary

The present study was adopted to evaluate the pharmacokinetics and dose linearity of fexofenadine after oral administration.

Detailed Description

The present study was adopted to evaluate the pharmacokinetics and dose linearity of fexofenadine after administration of single oral doses of 60 to 360 mg in an open-label, five-way crossover study.

Study Timeline

• Study Start: 2012-12
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-09
• Study First Submitted QC: 2013-01-10
• Last Update Submitted: 2013-01-10
• Study First Posted: 2013-01-14
• Last Update Posted: 2013-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

Inclusion Criteria

• At least 18 years old and not more than 45 healthy male volunteers
• Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame
• Who had passed all the screening parameters
• Free of any drug exposure known to interfere with the pharmacokinetics or assay of fexofenadine for at least 10 days prior to the study
• Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

Exclusion Criteria

• A clinically significant abnormal physical exam, medical history, or laboratory studies
• If they showed a sitting SBP of >140 or <100 mmHg, DBP > 90 or <60mm Hg, or a pulse rate of > 95 or < 50 beats/min at screening
• A history of serious intolerance, allergy, or sensitivity to fexofenadine
• The use of any prescription drug within the previous month or use of any over-the-counter medication (with the exception of acetaminophen) within the past 14 days
• A history of blood dyscrasias
• A history of alcohol or drug abuse within the past year
• Donation of blood during the 8 weeks prior to the study or plans to donate blood during or within 8 weeks of completing the study
• Unable to tolerate vein puncture and multiple blood samplings
• Any surgical/medical condition that might alter drug absorption, distribution, metabolism, or excretion
• Cannot follow instructions, in the opinion of the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
fexofenadine 120 mg	fexofenadine	Second dose strength
fexofenadine 240 mg	fexofenadine	Fourth dose strength
fexofenadine 60 mg	fexofenadine	First dose strength
fexofenadine 180 mg	fexofenadine	Third dose strength
fexofenadine 360 mg	fexofenadine	Fifth dose strength

Primary Outcome Measures

Name	Time	Method
Tolerability	Participants will be followed for the duration of study, an expected average of 5 weeks.	Tolerability was assessed based on changes in vital signs (temperature, blood pressure, pulse, and heart rate), measured before dosing in each period and approximately every 4 hours thereafter, and laboratory tests (hematology, biochemistry, liver function, and urinalysis), and performed at baseline and at the end of the study. In addition, a physician questioned volunteers about any adverse events occurring during the study, addressed them as necessary, and recorded them on the appropriate form. This physician was not blinded to treatment, but had no involvement in the study.