None listed
Conditions
Interventions
Intervention1: Tucatinib: 150 mg tablets
Single Dose, two period (11.00 hours pre dose to 48.00 hours post dose)
Oral administration with a washout period 06 days
study duration is 17 Days
Control In
Sponsors
BDR Pharmaceuticals Internationals Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Bioequivalence on Tucatinib 150 mg Tablets Manufactured by BDR Pharmaceuticals Internationals Pvt Ltd India Primary Objective of this study is to to assess the Bioequivalence on Tucatinib 150 mg Tablets with Tukysa® 150 mg Tablets in Healthy, Adult Human Subjects Under Fasting Conditions. hence outcome assessment is not applicable.Timepoint: 24 00.00 00.33 00.67 01.00 01.33 01.67 02.00 02.33 02.67 03.00 03.33 03.67 04.00 04.50 05.00 06.00 08.00 10.00 12.00 16.00 24.00 36.00 48.00 and 72.00 Dear Sir/Madam, Primary Objective of this study is to to assess the Bioequivalence on Tucatinib 150 mg Tablets with Tukysa® 150 mg Tablets in Healthy, Adult Human Subjects Under Fasting Conditions. hence outcome assessment is not applicable. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor the safety & tolerability in healthy adult human subjects under fasting conditions Primary Objective of this study is to to assess the Bioequivalence on Tucatinib 150 mg Tablets with Tukysa® 150 mg Tablets in Healthy, Adult Human Subjects Under Fasting Conditions. hence outcome assessment is not applicable.Timepoint: 24 00.00 00.33 00.67 01.00 01.33 01.67 02.00 02.33 02.67 03.00 03.33 03.67 04.00 04.50 05.00 06.00 08.00 10.00 12.00 16.00 24.00 36.00 48.00 & 72.00 Primary Objective of this study is to to assess the Bioequivalence on Tucatinib 150 mg Tablets with Tukysa® 150 mg Tablets in Healthy, Adult Human Subjects Under Fasting Conditions. hence outcome assessment is not applicable. | — |
Countries
India
Contacts
Public ContactDr Gokul Raj R
Spinos Lifescience and Research Pvt Ltd
Outcome results
None listed