Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions

Launched by DR. REDDY'S LABORATORIES LIMITED · May 27, 2010

Keywords

ClinConnect Summary

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra-D 24 hour ER Tablets of Aventis Pharmaceuticals Inc., USA in healthy, adult, human subjects under fasting conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Human subjects aged between 18 and 45 years (including both)
• • Subjects'weight within the normal range according to normal values for the Body Mass Index (18.5 to 24.9kgm2)with minimum of 50 kg weight.
• • Subjects with normal health as determined by personal medical history clinical examination and laboratory examinations within the clinically acceptable normal range.
• • Subjects having normal 12-lead electrocardiogram (ECG).
• • Subjects having normal chest X-Ray (P/A view).
• • Have a negative urine screen for drugs of abuse (including amphetamines,barbiturates, benzodiazepines, marijuana, cocaine, and morphine).
• • Have negative alcohol breath test.
• • Subjects willing to adhere to the protocol requirements and to provide written informed consent.
• Exclusion Criteria:
• Subjects will be excluded from the study, if they meet any of the following criteria:
• • Hypersensitivity to Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride or related drugs.
• • History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
• • History or presence of significant alcoholism or drug abuse in the past one year.
• • History or presence of significant smoking (more than 10 cigarettes or beedi's/day).
• • History or presence of significant asthma, urticaria or other allergic reactions.
• • History or presence of significant gastric and/or duodenal ulceration.
• • History or presence of significant thyroid disease, adrenal dysfunction, organic intracranial lesion such as pituitary tumour.
• • History or presence of cancer.
• • Difficulty with donating blood.
• • Difficulty in swallowing solids like tablets or capsules.
• • Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg.
• • Diastolic blood pressure less than SO mm Hg or more than 90 mm Hg.
• • Pulse rate less than 50/minute or more than 100/minute.
• • Oral temperature less than 95°F or more than 98.5°F.
• • Respiratory rate less than 12/minute or more than 20/minute
• • SUbjects who have used any prescription medication, within 14 days of period 01 dosing or OTC medication within 14 days of period 01 dosing.
• • Major illness during 3 months before screening.
• • Participation in a drug research study within past 3 months.
• • Donation of blood in the past 3 months before screening.
• • Subjects who have consumed xanthine-containing products (including caffeine, theobromines, etc.) within 48 hours prior to period 01 dosing.
• • Subjects who have consumed food or beverages containing grapefruit or pomelo within 14 days prior to period 01 dosing.