Comparative bioavailability study of Test product Fesoterodine Fumarate ER Tablets 8 mg compared with the reference product of Toviaz® (fesoterodine fumarate) Extended-Release Tablets 8 mg, in healthy, adult, human subjects, under fasting conditions.
- Registration Number
- CTRI/2019/04/018645
- Lead Sponsor
- MSN Laboratories Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Healthy human subjects within the age range of 18 to 45 years (inclusive of both).
2.Willingness to provide written informed consent to participate in the study.
3.Willing to abstain from use of any prescription and over the counter medications (vitamins and minerals through duration of the study) including medications which may interfere with pharmacokinetics of fesoterodine and tolterodine tartrate.
4.Body-mass index of ï?³ 18.5 kg/m2 and ï?£ 24.9 kg/m2, with body weight not less than 55 kg.
5.Absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluations, medical history or physical examination during the screening.
6.Normal 12-lead ECG.
7.Normal chest X-ray PA view.
8.Comprehension of the nature and purpose of the study and compliance with the requirement of the protocol.
9.Female Subjects
9.1Subject having negative serum β-hCG test (only for female volunteers)
9.2of 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, or
9.3post-menopausal for at least 1 year, or
9.4surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject).
1.Personal / family history of allergy or hypersensitivity reaction to fesoterodine and tolterodine tartrate or any component of the formulation.
2.Past history of anaphylaxis or angioedema
3.History or presence of urinary retention.
4.History or presence of severe constipation.
5.History or presence of narrow-angle glaucoma
6.History or presence of hepatic and renal impairment
7.History of use of CYP3A4 inhibitor (e.g., ketoconazole, itraconazole, clarithromycin, erythromycin, fluconazole, diltiazem, verapamil, grapefruit juice and cimetidine) within 14 days before Period I Check-In.
8.History or presence of myasthenia gravis
9.Known or suspected increased susceptibility to infection
10.History of consumption of alcohol for more than two years, or consumption of more than three alcoholic drinks per day or consumption of alcohol within 48 hours prior to check-in and during the study [one drink is equal to one unit of alcohol [one glass wine, half pint beer, and one measure (one ounce) of spirit]
11.History or presence of cancer
12.History or evidence of depression and/or suicidal thoughts or behaviour.
13.History or evidence of significant weight loss.
14.History of use of recreational drug or a history of drug addiction
15.History of seizure or psychiatric disorders
16.Inaccessibility of veins in left and right arm
17.Presence of any clinically significant abnormal values during screening e.g. significant abnormality of Liver Function Test (LFT), Renal (kidney) Function Test (RFT), etc.
18.History of donation of blood (one unit or 330 mL) within 3 months prior to study check-in or difficulty in donating blood
19.Recent history of dehydration from diarrhoea, vomiting or any other reason within period of 7 days prior to study check-in
20.Use of any prescribed or OTC medicinal products including vitamins and minerals during the within two weeks prior to investigational products administration in period I.
21.Any major illness in the past three months or any clinically significant on-going chronic medical illness e.g., congestive heart failure, hepatitis, pancreatitis etc.
22.Participation in a drug research study within past 3 months
23.Consumption of grape fruit juice, xanthine containing products and tobacco containing products or alcohol for within 48 hours to before check-in
24.Presence of disease markers of HIV 1 and 2, and hepatitis B and C virus
25.History or presence of significant easy bruising or bleeding
26.History or presence of recent significant trauma
27.Subject who have been on an abnormal diet (for whatever reason) during the four weeks preceding the study.
28.Female volunteers demonstrating a positive test for pregnancy during screening or currently breast-feeding
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the single oral dose bioequivalence of test product of Fesoterodine Fumarate ER Tablets 8 mg of MSN Laboratories Private Limited, India with that of reference product Toviaz® (fesoterodine fumarate) Extended-Release Tablets 8 mg of Pfizer Labs, Division of Pfizer Inc., USA in healthy, adult, human subjects under fasting conditions. <br/ ><br> <br/ ><br>Plasma PK parameters including Cmax AUC0-t and AUC0-â?? for Lacosamide in relevant treatmentsTimepoint: A pre-dose blood sample (0.00 hours) will be collected within 90 minutes before dosing in each period. <br/ ><br> <br/ ><br>Single venous blood sample will be withdrawn at pre-dose (0.00) and 1.00, 1.50, 2.00, 3.00, 3.50, 4.00, 4.25, 4.50, 4.75, 5.00, 5.25, 5.50, 5.75, 6.00, 6.33, 6.67, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose
- Secondary Outcome Measures
Name Time Method To characterise secondary PK parameters of test product Fesoterodine Fumarate ER Tablets 8 mg of MSN Laboratories Private Limited, India with that of reference product Toviaz® (fesoterodine fumarate) Extended-Release Tablets 8 mg of Pfizer Labs, Division of Pfizer Inc., USA in healthy human subjects under fasting conditions. <br/ ><br> <br/ ><br>Plasma PK parameters: Tmax, t1/2, Kel and AUC_% Extrap_ObsTimepoint: A pre-dose blood sample (0.00 hours) will be collected within 90 minutes before dosing in each period. <br/ ><br> <br/ ><br>Single venous blood sample will be withdrawn at pre-dose (0.00) and 1.00, 1.50, 2.00, 3.00, 3.50, 4.00, 4.25, 4.50, 4.75, 5.00, 5.25, 5.50, 5.75, 6.00, 6.33, 6.67, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00 and 48.00 hours post-dose