- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00835640
Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions
August 14, 2009 updated by: Teva Pharmaceuticals USA
A Relative Bioavailability Study of 180 mg Fexofenadine Hydrochloride Tablets Under Fed Conditions.
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 fed conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Dakota
-
Fargo, North Dakota, United States, 58102
- PRACS Institute, Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 2
|
1 x 180 mg
|
EXPERIMENTAL: 1
|
1 x 180 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cmax = Maximum Observed Concentration.
Time Frame: Blood samples collected over a 48 hour period.
|
Bioequivalence based on Cmax.
|
Blood samples collected over a 48 hour period.
|
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.
|
Bioequivalence based on AUC0-t.
|
Blood samples collected over a 48 hour period.
|
AUC0-inf = Area Under the Concentration-time Curve From Time Zero to Infinity.
Time Frame: Blood samples collected over a 48 hour period.
|
Bioequivalence based on AUC0-inf.
|
Blood samples collected over a 48 hour period.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Primary Completion (ACTUAL)
January 1, 2002
Study Completion (ACTUAL)
January 1, 2002
Study Registration Dates
First Submitted
January 30, 2009
First Submitted That Met QC Criteria
February 2, 2009
First Posted (ESTIMATE)
February 3, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
August 20, 2009
Last Update Submitted That Met QC Criteria
August 14, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01-862
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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