bioequivalence study of fexofenadine hcl 180 mg + pseudoephedrine hcl 240 mg er tablets of dr.reddy's under fed conditions

Conditions: Healthy

Summary: the purpose of this study is to 1. compare and evaluate the single dose, crossover, bioequivalence study of fexofenadine hcl 180 mg + pseudoephedrine hcl 240 mg er tablets and allegra-d 24 hr tablets. 2. monitor the adverse events and ensure the safety of subjects.

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 fed conditions.

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.

Keywords: bioequivalence fexofenadine hydrochloride + pseudoephedrine hydrochloride