Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

NCT01767272 | Completed DMC

• 1 other identifier: PPT2
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Fexofenadine; Pharmacokinetics; Bioavailability; Linearity; HPLC; Dose proportionality of fexofenadine in Egyptian volunteers

Outcome Measures

Primary Outcomes (1)

• Tolerability

  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.

  Participants will be followed for the duration of study, an expected average of 5 weeks.

Study Arms (5)

fexofenadine 60 mg

OTHER

First dose strength

Drug: fexofenadine

fexofenadine 120 mg

OTHER

Second dose strength

Drug: fexofenadine

fexofenadine 180 mg

OTHER

Third dose strength

Drug: fexofenadine

fexofenadine 240 mg

OTHER

Fourth dose strength

Drug: fexofenadine

fexofenadine 360 mg

OTHER

Fifth dose strength

Drug: fexofenadine

Interventions

fexofenadine DRUG

fexofenadine brand name

Also known as: Telfast

fexofenadine 120 mg; fexofenadine 180 mg; fexofenadine 240 mg; fexofenadine 360 mg; fexofenadine 60 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damanhour University: lead

MeSH Terms

Interventions

fexofenadine

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pharmaceutics, Faculty of Pharmacy

Study Record Dates

• First Submitted: January 9, 2013
• First Posted: January 14, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: January 14, 2013

Record last verified: 2013-01