Bioequivalence Study of desloratadine 5 mg manufactured by Pharma Chemi and Clarinex manufactured by Schering in 24 Healthy Volunteers under fasting condition

Bioequivalence of desloratadine tablets of Pharmachemi company with Clarinex tablets of Schering company ( Germany)

Cross over bioequivalence study

Sampling of volunteers is done in Khorazmi Plasma Center in Islamshahr. On the day of sampling, two 5 mg tablets of manufactured by Pharmachemi or Schering on two occasions and with a washout period of 7 days, will be administered orally with 240 ml of water to the volunteer. For example, if in the first phase he received the medicine made by Pharmachemi company, he will receive the brand medicine one week later. In each phase, 5 cc of blood sample will be taken before drug administration and at times 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 , 24 ,48, 72 hours after prescribing the medicine . One week after the start of the study, the volunteer's cooperation in this research ends. The way to cooperate in these three weeks is that the drug is prescribed in the first day and after that 72 hours blood sampling is done at the mentioned times after washout period of one week the other drug is administered and blood samples will be taken at the same time

inclusion criteria: A healthy male or female volunteer between the ages of 18 and 55 with a body mass index (BMI) between 19 and 30 - People who are willing to sign an informed consent form. Exclusion criteria:

12 people who take Pharmachemi tablets The second group: 12 people who take Schering pills on the same day

Plasma concentration and area under the curve of plasma concentration time of 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 the test drug, and the other half will receive numbers 13-24 and will receive the reference drug.

The tablets of Pharmachemi and Schering are both circular and white , so the candidate does not know which company's drug he will receive in each phase of the study. Additionally, the tubes of the volunteers' samples are also coded, so the analyzer does not know which company's drug he is analyzing, so only the researcher and the prescriber know which company's drug is being prescribed.

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bioequivalence study data is completely confidential and according to the contract with Pharmachemi Company, it should not be published anywhere.