DPF: Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers

Sponsor

Damanhour University (Other)

Overall Status

Completed

CT.gov ID

NCT01767272

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: fexofenadine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Official Title:

Dose Proportionality of Fexofenadine

Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: fexofenadine 60 mg First dose strength	Drug: fexofenadine fexofenadine brand name Other Names: Telfast
Other: fexofenadine 120 mg Second dose strength	Drug: fexofenadine fexofenadine brand name Other Names: Telfast
Other: fexofenadine 180 mg Third dose strength	Drug: fexofenadine fexofenadine brand name Other Names: Telfast
Other: fexofenadine 240 mg Fourth dose strength	Drug: fexofenadine fexofenadine brand name Other Names: Telfast
Other: fexofenadine 360 mg Fifth dose strength	Drug: fexofenadine fexofenadine brand name Other Names: Telfast

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.