An Open Label Balanced Randomized Single Dose Two Treatment Three Sequence Three Period Partial Replicate Reference Scaled Oral Bioequivalence Study Comparing Tucatinib 150 mg Tablets Manufactured By BDR Pharmaceuticals Internationals Pvt Ltd India With Tukysa 150 mg Tablets (Tucatinib 150 mg) Manufactured By M/S Seagen B V Evert van de Beekstraat 1 104 Schiphol (Netherlands) 1118CL In healthy Adult Human Subjects Under Fasting Conditions - NI

BDR Pharmaceuticals Internationals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•Normal healthy adult human subjects of age between 18-45 years and Body Mass Index (BMI) ranges between 18.50 kg/m2 to 29.99 kg/m2
•Subjects who have no evidence of underlying disease during screening and and check-in and whose screening is performed within 21 days of check in
•Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator
•Generally healthy as documented by 12-lead electrocardiogram (ECG) Chest X-Ray and clinical laboratory assessments
•Willing to consume Ovo lacto-vegetarian diet
•Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
•Generally healthy as documented by gynaecological examination and breast examination (for female subjects – period I only)
•Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to initiation of the study & a negative urine pregnancy test prior to check-in of each period

•Evidence of allergy or known hypersensitivity to Tucatinib or its inactive ingredients
•Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre-existing gallbladder disease
•Any major illness in the last three months or any significant ongoing chronic medical illness
•Renal or liver impairment
•History of alcohol addiction or abuse
•Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study
•Subjects who have taken any prescription medications within 14 days prior to study check-in and throughout the study and any over the counter medicinal products herbal medications within 07 days prior to study check-in and throughout the study
•Subject who had participated in any other study within the 90 days of check-in
•History of difficulty in swallowing
•History of difficulty in accessibility of veins
•Positive results for urine screen of drugs of abuse (Marijuana-THC amphetamine-AMP barbiturates-BAR cocaine-COC benzodiazepines-BZD and morphine-MOR) in urine prior to check-in of this study period
•Positive results for alcohol test prior to check-in of each period
•Female subjects demonstrating a positive pregnancy screen
•Female subjects who are currently lactating

发起方

BDR Pharmaceuticals Internationals Pvt Ltd