Bioequivalence Study of Dr.Reddy's Fexofenadine Hydrochloride 180 mg Tablets Under Fasting Conditions

NCT01066754 | Completed Phase 1

• 1 other identifier: 02040
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, 2-Way Crossover, Bioequivalence Study of Fexofenadine Hydrochloride 180 mg Tablets of Dr.Reddy's Laboratories Limited, and Allegra® 180 mg Tablets, Aventis Administered as 1 x 180 mg Tablet in Healthy Subjects under Fasting Conditions

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bioequivalence study of Dr. Reddys, Fexofenadine Hydrochloride 180 mg tablets

  2 months

Study Arms (2)

Fexofenadine

EXPERIMENTAL

Fexofenadine Hydrochloride 180 mg Tablets of Dr. Reddy's Laboratories Limited

Drug: Fexofenadine

Allegra

ACTIVE COMPARATOR

Allegra Tablets 180 mg of Aventis Pharmaceuticals Inc.,

Drug: Fexofenadine

Interventions

Fexofenadine DRUG

Fexofenadine Hydrochloride 180 mg Tablets

Also known as: Allegra 180 mg Tablets

Allegra; Fexofenadine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc.
• Web site, Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:
• Subjects will be females and/or males, smokers and non-smokers, 18 years of age and older.
• Female subjects will be post-menopausal or surgically sterilized.
• Post-menopausal status is defined as absence of menses for the past 12 months or hysterectomy with bilateral oophorectomy at least 6 months ago.
• Sterile status is defined as hysterectomy, bilateral oophorectomy or tubal ligation at least 6 months ago.

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Clinically significant illnesses within 4 weeks of the administration of study medication.
• Clinically significant surgery within 4 weeks prior to the administration of the study medication.
• Any clinically significant abnormality found during medical screening.
• Any reason which, in the opinion of the medical sub investigator, would prevent the subject from participating in the study.
• Abnormal laboratory tests judged clinically significant.
• Positive urine drug screen at screening.
• Positive testing for hepatitis B, hepatitis C or HN at screening.
• ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90; or heart rate less than 50 bpm or over 100 bpm) at screening.
• Subjects with BMl ≥ 30.0.
• History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than two units of alcohol per day (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
• History of drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
• Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical Sub investigator, contraindicates the subject's participation in this study.
• History of allergic reactions to fexofenadine hydrochloride or its ingredients.
• History of allergic reactions to heparin.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Anapharm Inc.,

Sainte-Foy Quebec, G1V 2K8, Canada

Location

MeSH Terms

Interventions

fexofenadine

Study Officials

• Eric Bicrell, M.D

  Anapharm

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2010
• First Posted: February 10, 2010
• Study Start: April 1, 2002
• Primary Completion: May 1, 2002
• Study Completion: May 1, 2002
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

CA (1)