Comparison of equivalence of two different drug product interms of absorption, distribution, metabolism & excretion in healthy adult human subjects

Not Applicable

Completed

• Registration Number: CTRI/2024/02/062604
• Lead Sponsor: BDR Pharmaceuticals Internationals Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-03-05
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: BA/BE
• Study Design: Not specified