Bioequivalence study of Sunitinib 50 mg capsule manufactured by Zistdaru Danesh (Sunixha) versus Sutent 50 mg in healthy volunteers in the fasted condition

Bioequivalence Study of Sunitinib 50 mg capsules manufactured by Zistdaru Danesh company (Sunixha) versus the originator brand (Sutent) manufactured by Pfizer company

Bioequivalence study, crossover, single-blinded, 24 healthy volunteers. Simple randomization was used for randomization.

The study has two series of healthy volunteers and is single-blinded, cross-over, and fasting. The study will take two 72-hour periods to complete. There are two weeks between these two times. The study's candidates are divided into two groups for the initial phase. A test capsule is given to the first group, while a brand capsule is given to the second. Volunteers take blood samples both before and after administering the medication. Following drug extraction, samples are prepared for examination. The first group will take the brand capsule during the second period, while the second group will take the trial capsule. These actions are carried out in Tabriz's Radin Laboratory.

Inclusion criteria: General health (liver, heart, and kidney), Body Mass Index (18-28), Informed consent, Age (18-55 years old) Exclusion criteria: Smoking, History of cardiovascular disease, History of liver and kidney disease, Alcohol and drug addiction, History of allergy to Sunitinib

Intervention group 1: Sutent 50 mg capsule as a reference Intervention group 2: Sunixha 50mg as a test Volunteers are divided into two groups. The first group consumes test medicine, and the second group consumes brand medicine. In the second period, which is run after two weeks, the first group will consume the brand and the second group will consume the test medicine.

Maximum drug concentration, Time to reach maximum drug concentration, Half-life of drug

People in the mentioned age group are invited to participate through the advertisement. After that, people who are in good health are selected. Each candidate receives a number between 1 and 24. A plastic ball with the numbers inscribed on it is poured into a container, then stirred. Next, balls are randomly pulled out of the container. Zistdaru Danesh's medicine is considered to be the first 12 numbers, and the recipient of the original brand is considered to be the second 12 numbers. The subjects are unaware of taking either the brand or test medication. The first group will take brand-name medication during the second session, which is conducted a week later, while the second group will take a test medication.

A single-blinded clinical trial (volunteers) was used in this study. The executor removes the test Sunitinib and Originator brand capsules from their packaging and places them in coordinated cans. Volunteers won't be made aware of the brand or experimental dose form.

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