Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Damanhour University
• Treatments: Fexofenadine; Terfenadine

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.