In-vivo Bioequivalence Study of Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) of The Test Drug manufactured by Dr. Abidi Pharmaceutical Company in Compared with The Reference Drug NURTEC® 75 mg

In-vivo Bioequivalence Study of Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) of The Test Drug manufactured by Dr. Abidi Pharmaceutical Company in Compared with The Reference Drug NURTEC® 75 mg

Bioequivalence study, Cross-over design, Single dose, Single-blinded, 24 healthy volunteers, Two period, one week wash out period, Simple randomization method will be used.

This single-blind, two-period crossover study was conducted on two groups of healthy volunteers at Radin Shimi Company in Tabriz. Each period lasted 48 hours, with a one -week washout interval between them. In the first period, based on computer-generated randomization, Group 1 received the reference drug while Group 2 received the test drug. In the second period, the treatments were switched. The study was single-blinded, meaning that participants were unaware whether they received the test or reference drug during either sampling period.

Inclusion criteria: Volunteers in good general health, including liver, heart, and kidney health; provision of informed consent to participate in the study; body mass index (BMI) between 18 and 30 kg/m²; and age between 18 and 55 years. Exclusion criteria: Smoking, pregnancy, history of hypersensitivity to the study drug, and alcohol consumption.

Intervention group one receives Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) of the test drug manufactured by Dr.Abidi pharmacutical company in the first round, and in the second round, after one-week washout period, the drug NURTEC® 75 mg . Intervention group No.2 receives the drugs in the switched order.

The concentration of the drug in blood, Time to reach maximum blood concentration, Extent of absorption

Initially, volunteers are screened according to the study inclusion and exclusion criteria, and 24 eligible volunteers are selected. Randomization is performed using Microsoft Excel and the RAND() function. For this purpose, random values are generated for numbers 1 to 24, and the order of these numbers is randomly determined based on the generated values. Each volunteer is then assigned a unique number according to the randomization list and receives an identification card containing the assigned number. During the first study period, volunteers assigned even numbers receive the reference drug (R), while those assigned odd numbers receive the test drug (T). In the second period, the treatments are switched in a crossover manner, so that volunteers who received the reference drug in the first period receive the test drug in the second period, and vice versa. The final randomization list is kept unchanged after preparation and used for study implementation.

This study is a single-blind (participant) clinical trial Rimegepant 75 mg Orally Disintegrating Tablet (RIPEVA®) of The Test Drug manufactured by Dr. Abidi Pharmaceutical Company and the original brand are removed from their packaging by the operator and placed in identical, coded cans. Volunteers are unaware of the type of drug or test they are receiving.

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