Dose Proportionality of Fexofenadine in Healthy Human Egyptian Volunteers (DPF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sally Helmy, PhD, CPHQ, Damanhour University
ClinicalTrials.gov Identifier:
NCT01767272
First received: January 9, 2013
Last updated: January 10, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Healthy
Drug: fexofenadine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Dose Proportionality of Fexofenadine

Resource links provided by NLM:


Further study details as provided by Damanhour University:

Primary Outcome Measures:
  • Tolerability [ Time Frame: Participants will be followed for the duration of study, an expected average of 5 weeks. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 25
Study Start Date: December 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
fexofenadine 60 mg
First dose strength
Drug: fexofenadine
fexofenadine brand name
Other Name: Telfast
fexofenadine 120 mg
Second dose strength
Drug: fexofenadine
fexofenadine brand name
Other Name: Telfast
fexofenadine 180 mg
Third dose strength
Drug: fexofenadine
fexofenadine brand name
Other Name: Telfast
fexofenadine 240 mg
Fourth dose strength
Drug: fexofenadine
fexofenadine brand name
Other Name: Telfast
fexofenadine 360 mg
Fifth dose strength
Drug: fexofenadine
fexofenadine brand name
Other Name: Telfast

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sally Helmy, PhD, CPHQ, Lecturer of Pharmaceutics, Faculty of Pharmacy, Damanhour University
ClinicalTrials.gov Identifier: NCT01767272     History of Changes
Other Study ID Numbers: PPT2
Study First Received: January 9, 2013
Last Updated: January 10, 2013
Health Authority: Egypt: Institutional Review Board

Keywords provided by Damanhour University:
Fexofenadine
Pharmacokinetics
Bioavailability
Linearity
HPLC
Dose proportionality of fexofenadine in Egyptian volunteers

Additional relevant MeSH terms:
Fexofenadine
Terfenadine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014