Fexofenadine Hydrochloride 180 mg Tablets Under Non-Fasting Conditions

NCT00835640 | Completed Phase 1 Results

• 1 other identifier: R01-862
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax = Maximum Observed Concentration.

  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)

  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.

  Bioequivalence based on AUC0-inf.

  Blood samples collected over a 48 hour period.

Study Arms (2)

1

EXPERIMENTAL

Drug: Fexofenadine 180 mg tablets

2

ACTIVE COMPARATOR

Drug: ALLEGRA® 180 mg tablets

Interventions

Fexofenadine 180 mg tablets DRUG

1 x 180 mg

1

ALLEGRA® 180 mg tablets DRUG

1 x 180 mg

2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (1)

PRACS Institute, Ltd.

Fargo, North Dakota, 58102, United States

Location

MeSH Terms

Interventions

fexofenadine

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Manager, Biopharmaceutics

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• James D Carlson, Pharm. D.

  PRACS Institute, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 3, 2009
• Study Start: January 1, 2002
• Primary Completion: January 1, 2002
• Study Completion: January 1, 2002
• Last Updated: August 20, 2009
• Results First Posted: August 4, 2009

Record last verified: 2009-08

Locations

US (1)