CTRI/2019/04/018644尚未招募未知
An open label, balanced, randomized, two-treatment, two-period, two-sequence, two-way cross-over, single dose, oral bioequivalence study of Fesoterodine Fumarate ER Tablets 8 mg of MSN Laboratories Private Limited, India and Toviaz® (fesoterodine fumarate) Extended-Release Tablets 8 mg of Pfizer Labs, Division of Pfizer Inc., USA, in healthy, adult, human subjects under fed conditions. - Asian
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •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).
排除标准
- •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
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