Clinical trial to study the taste masking ability of orally dissolving films of fexofenadine hydrochloride
- Registration Number
- CTRI/2013/02/003351
- Lead Sponsor
- Sri Venkateshwara College of Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1) subjects aged between 18 to 45 both inclusive
2) Subject weight +/- 15% of ideal weight chart of LIC of India for non medical cases
3)Normal health as determined by personnel medical history and clinical examination
4) Subjects able to communicate effectively
5) Subjects willing to adhere to protocol requirements.
1) hypersensitivity to fexofenadine HCl or related drugs
2) History or presence of allergic rhinitis, asthma, urticaria, anaphylaxis
3) History or presence of significant smoking (more than 10 cigarettes or bidis/day) or consumption of tobacco products
4) History or presence of significant alcoholism or drug abues in the past one year
5) History or presence of significant gastric and duodenal ulceration
6)History or presence of significant sour tounge and oral ulcers
7)History or presence of cancer
8) Use of any prescribed medication during last tow weeks or OTC medical products during last one week preceding the first dosing
9) Major illness during one month before screening
10) Subjects who have been on an abnormal diet for whatever reason during the four week during the screening
11) Participation in the drug research study within past 3 months
12) Subjects who show sensitivity to the 1/10th concentration of standard quinine solution or super/non-taster by PROP method
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Some of the film formulation tested could significantly mask the taste effectively when compared to plain drug. the films disintegrated from 10 to 60 secsTimepoint: 60 sec
- Secondary Outcome Measures
Name Time Method The formulated films were acceptable to the subjects in terms of palatability and disintegration time.Timepoint: Not applicable