Single dose oral bioavailability study of Flavoxate HCl controlled release Tablets of both 600mg & 800 mg once a day and Flavoxate Tablet200 mg, thrice a day in healthy adult male subjects.
- Registration Number
- CTRI/2020/04/024700
- Lead Sponsor
- Martin Harris Laboratory Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
BMI: 18.5 to 30.0 weight in kg/(height in meter)2 both inclusive.
Selection of subjects for the study will be done based on assessment against the inclusion and exclusion criteria mentioned in the protocol.
Subjects from the pool of healthy volunteers who were screened within 28 days prior to the
first dosing day will be considered as potential participants in the study.
Subjects must be enrolled in the study only after providing written informed consent.
Volunteers must not be enrolled in the study if they meet any one of the following criteria:
1) History of allergic responses to Flavoxate, or other related drugs, or any of its
formulation ingredients.
2) Have significant diseases or clinically significant abnormal findings during screening,
[medical history, physical examination, laboratory evaluations, ECG, chest X-ray
recording and ophthalmic examination (tonometry)].
3) Any disease or condition like diabetes, psychosis or others which might compromise the
haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central
nervous system or any other body system.
4) History or presence of bronchial asthma.
5) Use of any hormone replacement therapy within 3 months prior to the first dose of study
medication.
6) A depot injection or implant of any drug within 3 months prior to the first dose of study
medication.
7) Use of enzyme-modifying drugs within 30 days prior to the first dose of study
medication.
8) History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
9) Smokers who smoke 10 or more cigarettes per day or 20 or more biddies per day or
those who cannot refrain from smoking during the study period.
10) History of difficulty with donating blood or difficulty in accessibility of veins.
11) A positive hepatitis screen (includes subtypes B & C).
12) A positive test result for HIV antibody and / or syphilis (RPR/VDRL).
13) Volunteer who have received a known Investigational drug within ten elimination half
life of the administered drug prior to the first dose of study medication or have donated
blood or loss of blood 50 mL to 100 mL within 30 days or 101 mL to 200 mL within 60
days or >200 mL within 90 days (excluding volume drawn at screening for this study)
prior to first dose of study medication, whichever is greater.
14) History of difficulty in swallowing or of any gastrointestinal disease which could affect
drug absorption.
15) Intolerance to venipuncture.
16) Any food allergy, intolerance, restriction or special diet that, in the opinion of the
Principal Investigator or Sub-Investigator, could contraindicate the volunteerââ?¬•s
participation in this study.
17) Institutionalized volunteer.
18) History of galactose intolerance, the Lapp Lactose deficiency and glucose galactose
malabsorption.
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare and evaluate the oral bioavailability of two test formulations of Flavoxate XR Tablet 600 mg, once a day (T1) and Flavoxate XR Tablet 800 mg, once a day (T2) with that of reference formulation of Flavoxate Tablet 200 mg, thrice a day (R) in healthy, adult, male subjects under fasting conditions. <br/ ><br>To monitor the safety and tolerability of the subjects.Timepoint: In each period, total 19 venous blood samples for Test Products and a total 34 venous blood samples for Reference Product will be collected at Pre dosing & post dosing Time points mentioned in a separate email as data is exceeding 500 characters
- Secondary Outcome Measures
Name Time Method To monitor the safety and tolerability of the subjectsTimepoint: Prior to Check-in and checkout, Prior to morning dosing, At 3.0, 7.0 and 15.0 hours (�± 40 minutes) after each morning dosing, At about 24.0 hours post morning dose; Adverse Event Monitoring throughout the study