Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

NCT ID: NCT01767272

Last Updated: 2013-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-01-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

fexofenadine 60 mg

First dose strength

Group Type: OTHER

fexofenadine

Intervention Type: DRUG

fexofenadine brand name

fexofenadine 120 mg

Second dose strength

Group Type: OTHER

fexofenadine

Intervention Type: DRUG

fexofenadine brand name

fexofenadine 180 mg

Third dose strength

Group Type: OTHER

fexofenadine

Intervention Type: DRUG

fexofenadine brand name

fexofenadine 240 mg

Fourth dose strength

Group Type: OTHER

fexofenadine

Intervention Type: DRUG

fexofenadine brand name

fexofenadine 360 mg

Fifth dose strength

Group Type: OTHER

fexofenadine

Intervention Type: DRUG

fexofenadine brand name

Interventions

fexofenadine

fexofenadine brand name

Intervention Type: DRUG

Other Intervention Names

Telfast

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Damanhour University

OTHER

Sponsor Role: lead

Responsible Party

Sally Helmy, PhD, CPHQ

Lecturer of Pharmaceutics, Faculty of Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PPT2

Identifier Type: -

Identifier Source: org_study_id