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IRCT20220209053979N12 IRCT 2023-12-07 Tasnim Pharmaceutical Bioequivalence of sustained release Diclofenac 100 mg capsule manufactured by Tasinm Pharmaceutical and Diclofenac 100 mg capsule manufactured by Ratio pharm Bioequivalence Study of sustained release Diclofenac 100 mg capsule manufactured by Tasinm Pharmaceutical and and Diclofenac 100 mg capsule menufactured by Ratio pharm in 24 Healthy volunteers under fasting condition 2023-12-21 anticipated 24 Complete https://irct.ir/trial/74057 interventional Randomization: N/A, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Other, Blinding description: 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. Bioequivalence A crossover bioequivalence study in 24 healthy volunteers. Intervention 1: Intervention group: Oral administration of one Diclofenac 100 mg capsule manufactured by Tasnim Pharmaceutical to 12 healthy volunteers under fasting condition with 240 ml of water. Then 12 blood samples are taken from volunteers at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24 hours after drug administration. In the second phase after a wash out period of one week , this group will take Ratio pharm medicine and blood samples are taken at the same times. Intervention 2: Intervention group: Oral administration of one Diclofenac 100 mg capsule manufactured by Ratio pharm to 12 healthy volunteers under fasting condition with 240 ml of water. Then 12 blood samples are taken from volunteers at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24 hours after drug administration. In the second phase after a wash out period of one week , this group take Tasnim Pharmaceutical medicine and blood samples are taken at the same times. No - There is not a plan to make this available Justification or reason for not sharing IPD is The bioequivalence study data is completely confidential and according to the contract with Tasnim Pharmaceutical Company, it should not be published anywhere.
public Roya Talari
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
Islamshar Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center scientific Roya Talari
No. 13, Shehamat 1st Alley, Ali Ibn Abitalib St., Namaz Square,
Islamshar Iran (Islamic Republic of) 3313679886 +98 21 5669 4726 talari_r@yahoo.com Kharazmi Plasma Center Iran (Islamic Republic of) Healthy male or female volunteers Body mass index (BMI) between 18 - 30 Volunteers who are willing to sign an informed consent form 18 years 55 years Both History of allergic reaction to memantin or formulation components Taking any type of medicine in the 14 days before the start of the study Participation in any type of clinical study in the last month Other Other Intervention group: Oral administration of one Diclofenac 100 mg capsule manufactured by Tasnim Pharmaceutical to 12 healthy volunteers under fasting condition with 240 ml of water. Then 12 blood samples are taken from volunteers at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24 hours after drug administration. In the second phase after a wash out period of one week , this group will take Ratio pharm medicine and blood samples are taken at the same times. Intervention group: Oral administration of one Diclofenac 100 mg capsule manufactured by Ratio pharm to 12 healthy volunteers under fasting condition with 240 ml of water. Then 12 blood samples are taken from volunteers at 0, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 24 hours after drug administration. In the second phase after a wash out period of one week , this group take Tasnim Pharmaceutical medicine and blood samples are taken at the same times. Plasma concentration time profile, maximum plasma concentration, AUC. Timepoint: 0 ، 1، 1.5 ، 2 ، 2.5 ، 3، 4، 5، 6 ، 8، 10, 24 h after drug administration. Method of measurement: Liquid chromatography with mass spectrophotometry. Calculation of pharmacokinetic parameters like Cmax, AUC of test and reference drug. Timepoint: Same as primary outcome. Method of measurement: Pharmacokientic parameters are calculated by excel. Tasnim Pharmaceutical Approved 2023-11-26 Ethics Committee of Tehran University of Medical Science Tehran University of Medical Science, 16 Azar St., Tehran Tehran Iran (Islamic Republic of)