Overview

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.