Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00835276
First received: January 30, 2009
Last updated: August 14, 2009
Last verified: August 2009
  Purpose

This study will compare the relative bioavailability (rate and extent of absorption) of 180 mg Fexofenadine Hydrochloride tablets manufactured for TEVA Pharmaceuticals Industries, Ltd. with that of 180 mg ALLEGRA® Tablets by Aventis Pharmaceuticals, Inc. following a single oral dose (1 x 180 mg tablet) in healthy adult volunteers under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Fexofenadine 180 mg tablets
Drug: ALLEGRA® 180 mg tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Relative Bioavailability Study of 180 mg Fexofenadine Hydrochloride Tablets Under Fasting Conditions.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceuticals USA:

Primary Outcome Measures:
  • Cmax = Maximum Observed Concentration. [ Time Frame: Blood samples collected over a 48 hour period. ] [ Designated as safety issue: No ]
  • AUC0-t = Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (Per Participant) [ Time Frame: Blood samples collected over a 48 hour period. ] [ Designated as safety issue: No ]
  • AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity. [ Time Frame: Blood samples collected over a 48 hour period. ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: March 2002
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Fexofenadine 180 mg tablets
1 x 180 mg
Active Comparator: 2 Drug: ALLEGRA® 180 mg tablets
1 x 180 mg

Detailed Description:

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All volunteers selected for this study will be healthy, non-smoking men and women 18 to 55 years of age, inclusive, at the time of dosing. The volunteer's body mass index (BMI) is less that or equal to 30.
  • If female and :

    • of child bearing potential, is practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence; or
    • is postmenopausal for at least 1 year; or
    • is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).

Exclusion Criteria:

  • Volunteers with a recent history of drug or alcohol addiction or abuse.
  • Volunteers with the presence of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine, or neurologic system(s) or psychiatric disease (as determined by the clinical investigators).
  • Volunteers whose clinical laboratory test values are outside the accepted reference range and when confirmed on re-examination are deemed to be clinically significant.
  • Volunteers demonstration a positive hepatitis B surface antigen screen, hepatitis C antibody screen or a reactive HIV antibody screen.
  • Volunteers demonstrating a positive drug abuse screen when screened for this study.
  • Female volunteers who are currently breast feeding.
  • Female volunteers who are demonstrating a positive pregnancy screen.
  • Volunteers with a history of allergic response(s) to fexofenadine or related drugs.
  • Volunteers with a history of clinically significant allergies including drug allergies.
  • Volunteers with a clinically significant illness during the 4 weeks prior to Period I dosing (as determined by the clinical investigators).
  • Volunteers who currently use or reports using tobacco or nicotine-containing products within 90 days prior to Period I dosing.
  • Volunteers who have taken any drug known to induce or inhibit hepatic drug metabolism in the 30 days prior to Period I dosing.
  • Volunteers who report donating greater than 150 mL of blood within 30 days prior to Period I dosing. All subjects will by advised not to donate blood for four weeks after completing the study.
  • Volunteers who have donated plasma (e.g. plasmapheresis) within 14 days prior to Period I dosing. All subjects will be advised not to donate plasma for four weeks after completing the study.
  • Volunteers who report receiving any investigational drug within 30 days prior to Period I dosing.
  • Volunteers who report taking any prescription medication in the 14 days prior to Period I dosing, with the exception of topical products without systemic absorption.
  • Volunteers who have been on an abnormal diet during the 28 days prior to Period I dosing.
  • Volunteers who report an intolerance of direct venipuncture.
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00835276

Locations
United States, North Dakota
PRACS Institute, Ltd.
Fargo, North Dakota, United States, 58102
Sponsors and Collaborators
Teva Pharmaceuticals USA
Investigators
Principal Investigator: James D Carlson, Pharm. D. PRACS Institute, Ltd.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00835276     History of Changes
Other Study ID Numbers: R01-861
Study First Received: January 30, 2009
Results First Received: June 30, 2009
Last Updated: August 14, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence
Healthy Subjects

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 August 21, 2014