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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Dr. Reddy's Laboratories Limited
• Treatments: Ephedrine; Fexofenadine; Pseudoephedrine; Terfenadine

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.