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

Launched by DR. REDDY'S LABORATORIES LIMITED · Feb 9, 2010

Keywords

ClinConnect Summary

The objective of this study is to compare the rate and extent of absorption of fexofenadine hydrochloride 180 mg tablets (test) versus Allegra® (reference) administered as 1 x 180 mg tablet under fasting conditions. Single oral dose (1 x 180 mg) in each period with a washout of at least 7 days between doses.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• * 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.
• • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, rifampin/rifabutin; examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin, ketoconazole, MAO inhibitors, neuroleptics, verapamil, quinidine), use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
• • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural products, vitamins, garlic as supplement)within 7 days prior to administration of study medication, except for topical products without systemic absorption.
• • Subjects who have a depot injection or an implant of any drug 3 months prior to administration of study medication.
• * Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
• • less than 300 mL of whole blood within 30 days or
• • 300 mL to 500 mL of whole blood within 45 days or
• • more than 500 mL of whole blood within 56 days.
• • Smoking more than 25 cigarettes per day.
• Additional exclusion criteria for females only:
• • Breast-feeding subjects.
• • Positive urine pregnancy test at screening (performed on all females).