Bioequivalence Study of sustained release memeantin 21 mg capsule manufactured by Tasinm Pharmaceutical and Namenda 21 capsule manufactured by Forest Laboratory in 24 Healthy Volunteers under fasting condition

Comparison of the bioavailability of memantin sustained release capsules after a single dose of 21mg, manufactured by Tasnim Pharmaceutical and Forest Laboratory .

The study is a cross-over double-blind study. 24 healthy volunteers using the random option in excel software will be assigned a code, and depending on the code, the first half will receive the test, and the second half will receive reference drugs. In each phase of the study, 15 blood samples will be received from the individual.

On the day of sampling, after 10 hours of fasting, the volunteers come to Kharazmi Plasma Center in Islamshahr ( No. 13, 1st Shehamat Alley, Ali Ibn Abitalib St., Namaz Square,) and receive one capsule of the test or reference drug with 240 ml of water and blood samples are taken at 0, 1, 2, 4, 5, 6, 7, 8, 9, 10, 11, 12, 24, 48, 72 hours after drug administration, after plasma separation, the samples were transferred to a -70 freezer and finally the concentration of drug in plasma will be determined according to the LCMSMS method.After a 3-weeks wash out period, the process of drug administration is done vise versa.

Inclusion criteria: Healthy adult male (18 - 55 yrs) and sterile or post menopausal female subjects, Body weight must be ≥50 kg and <100 kg, with a body mass index (BMI) >18 but <33.Laboratory parameter values must fall within the normal range Exclusion criteria: history of allergic reaction to memantion. Smokers or user of tobacco products , history of arrhythmia.

Comparing the blood concentration of memantin if Tasnim Pharmaceutical and Namenda manufactured by Forest Laboratory

Plasma concentration caused by test and reference drug

Using the rand option of the Excel software, the candidates are divided into two groups, and half of them will receive numbers 1-12 and get the test drug, and the other half will receive numbers 13-24 and will take the reference drug.

The drug (test or reference drug) is removed from the original packaging the day before the study and packaged in small disposable containers. Therefore, it is not in the original packaging and also the visual appearance and size of the test and reference capsules are the same , none of the volunteer nor the prescriber know which drug is being administered. The relevant code is also written on the sample collecting tubes of each volunteer, neither the analyzer knows the test or reference drug sample is analyzing.

The bioequivalence study data is completely confidential and according to the contract with Shafa Pharmaceutical Company, it should not be published anywhere.