- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01888718
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover, Oral Bioequivalence Study 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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Hyderabad, Andhra Pradesh
-
Balanagar, Hyderabad, Andhra Pradesh, India, 500 037
- Bioserve Clinical Research Private Limited
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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)
Exclusion Criteria
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.
xvii. Participated in any other clinical investigation using experimental drug/donated blood in past 90 days before the date of start of study.
xviii. Confirmed positive in urine pregnancy test.
xix. Female detected to be pregnant, breast feeding or who is likely to become pregnant during the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fexofenadine Hydrochloride Orally Disintegrating
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr.Reddy's Laboratories Ltd
|
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Other Names:
|
Active Comparator: ALLEGRA
ALLEGRA orally disintegrating tablets 30 mg of Sanofi Aventis
|
Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under curve (AUC)
Time Frame: 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
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Vimal Teja, MD, Bioserve Clinical Research Private Limited
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 671/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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