Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition

NCT01888718 | Completed Phase 1 DMC

• 1 other identifier: 671/10
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing fexofenadine hydrochloride) Orally Disintegrating Tablets 30 mg of Sanofi - aventis U.S. LLC, Bridgewater, NJ 08807 in healthy, adult, human subjects under fasting conditions. To monitor adverse events and ensure the safety of subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Area under curve (AUC)

  Pre-dose (0.0) and 0.167, 0.33, 0.50, 0.75, 1.25, 1.5, 1.75, 2, 2.33, 2.67, 3, 3.50, 4, 5, 6, 8, 10, 12, 16, 24, 36 and 48 hrs

Study Arms (2)

Fexofenadine Hydrochloride Orally Disintegrating

EXPERIMENTAL

Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr.Reddy's Laboratories Ltd

Drug: Fexofenadine Hydrochloride

ALLEGRA

ACTIVE COMPARATOR

ALLEGRA orally disintegrating tablets 30 mg of Sanofi Aventis

Drug: Fexofenadine Hydrochloride

Interventions

Fexofenadine Hydrochloride DRUG

Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg

Also known as: ALLEGRA

ALLEGRA; Fexofenadine Hydrochloride Orally Disintegrating

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• i. Provide written informed consent.
• ii. Must be healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg.
• iii. Having a body mass index between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2.
• iv. Must be of normal health as determined by medical history, physical examination and laboratory investigation performed within 28 days prior to the commencement of the study. (Laboratory values must be within normal limits or considered by the physician / investigator to be of no clinical significance).
• v. Female Subjects
• of child bearing potential practicing an acceptable method of birth control for the duration of the study as judged by the investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), or abstinence.
• surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)

You may not qualify if:

• i.Incapable of understanding the informed consent.
• ii. Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg.
• iii. Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg.
• iv. Oral temperature is below 95.0°F or above 98.6°F.
• v. Pulse rate below 50/min or above 100/min.
• vi. History of hypersensitivity or idiosyncratic reaction to investigational drug product or any other related drugs.
• vii. Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function.
• viii. Consumption of grapefruit for the past ten days prior to the check-in, in each period.
• ix. Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking during sample collection period.
• x. Habit of tobacco chewing.
• xi. Habit of alcoholism and difficulty in abstaining from alcohol during the sample collection period.
• xii. Difficulty in abstaining from xanthine containing food or beverages (like tea, coffee, chocolates and cola drinks) during the sample collection period.
• xiii. Intake of over the counter (OTC) or prescribed medications and enzyme modifying medication or systemic medication for the last 30 days before dosing.
• xiv. Clinically significant abnormalities and / or with significant diseases. xv. Confirmed positive in alcohol screening.
• xvi. Confirmed positive in selected drug of abuse.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (1)

Bioserve Clinical Research Private Limited

Bālānagar, Hyderabad, Andhra Pradesh, 500 037, India

Location

MeSH Terms

Interventions

fexofenadine

Study Officials

• Dr. Vimal Teja, MD

  Bioserve Clinical Research Private Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: February 1, 2011
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: June 28, 2013

Record last verified: 2011-03

Locations

IN (1)