Dose Proportionality of Fexofenadine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damanhour University
- Enrollment
- 25
- Primary Endpoint
- Tolerability
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- 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.
Arms & Interventions
fexofenadine 180 mg
Third dose strength
Intervention: fexofenadine (Drug)
fexofenadine 60 mg
First dose strength
Intervention: fexofenadine (Drug)
fexofenadine 120 mg
Second dose strength
Intervention: fexofenadine (Drug)
fexofenadine 240 mg
Fourth dose strength
Intervention: fexofenadine (Drug)
fexofenadine 360 mg
Fifth dose strength
Intervention: fexofenadine (Drug)
Outcomes
Primary Outcomes
Tolerability
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sally Helmy, PhD, CPHQ
Lecturer of Pharmaceutics, Faculty of Pharmacy
Damanhour University