Bioequivalence study of Miglustat 100 mg capsule (Miglutan)manufactured by Zistdaru Danesh versus originator brand (Zavesca) in healthy volunteers in the fasted condition

Bioequivalence Study of Miglustat 100 mg capsule manufactured by Zistdaru Danesh company (Miglutan) versus originator brand (Zavesca) manufactured by Janssen company

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

The study is a single-blinded, cross-over and fasting, and on two series of healthy volunteers. The study will be done in two periods (48h). The interval between these two periods is one week. In the first round of the study, the candidates divide into two groups. the first group receives a test capsule and the second group receives a brand capsule. Blood samples are collected immediately before and after drug administration by volunteers. Then, drug extraction is done and samples are ready for analysis. In the second period, the first group will consume the brand capsule, and the second group will consume the test capsule. These steps are performed in Radin Laboratory in Tabriz.

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 Miglustat

Intervention group 1: Zavesca 100mg capsule manufactured by Janssen company as a reference Intervention group 2: Miglutan 100 mg capsule manufactured by Zistdaru Danesh company as a test. Volunteers are divided into 2 groups. The first group consumes test medicine and the second group consumes brand one. In the second period which is run after one week, the first group will consume the brand and the second group will consume the test medicine.

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

People in the mentioned age group are invited to participate through the advertisement. People are then checked for health and healthy volunteers are identified. Each candidate is assigned a number from 1 to 24. The numbers are written on a plastic ball, poured into a container, and mixed. The balls are then removed randomly from the container. The first 12 no.s are considered as (first sequence: Zistdaru Danesh's medicine ) and the second 12 no.s are considered as (second sequence: originator brand recipient). The volunteers don't have any information about taking the test drug or brand drug. In the second period that is run after one week, the First group will consume brand medicine and the second group will consume test one.

This study is a single-blinded clinical trial (volunteers). Zistdaru Danesh's Miglustat and Originator brand capsules are removed from their packaging by the executor and placed in similar and coded cans. Volunteers will not be informed about receiving the brand or test dosage form

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