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IRCT20230222057495N8 IRCT 2023-08-07 Sami Saz Pharmaceutical Company Bioequivalence study of dapoxetine 60 mg tablet Bioequivalence study of dapoxetine 60 mg tablet of Sami Saz pharmaceutical company compared to dapoxetine 60 mg sample of Menarini company in England on healthy volunteers 2023-08-11 anticipated 24 Complete https://irct.ir/trial/71742 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence ---. Intervention 1: Intervention group 1: includes the oral intake of Dapoxetine 60 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blood will be taken from the volunteers at time intervals before the start of drug use and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours after drug use. The cross-over study consists of two phases (oral administration of one 60 mg dapoxetine tablet per study for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Dapoxetine plasma concentration is determined by liquid chromatography mass - spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods. Intervention 2: Intervention group 2: includes the oral consumption of 60 mg dapoxetine tablets from Menarini company of England, on 24 healthy fasting volunteers. 5 ml of blood is taken from the volunteers at time intervals before the start of drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours after drug administration. The crossover study consists of two phases (prescribing one 60 mg dapoxetine tablet orally in each study for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Dapoxetine plasma concentration is determined by liquid chromatography mass - spectrometry. The analysis of the results will be based on ANOVA and t-test statistical methods. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Monireh Jalalipour
No. 419, Azadegan Square, Imam Khomeini Boulevard
Mahdasht Karaj Iran (Islamic Republic of) 3188913179 +98 26 3731 8748 info@naplab.ir Nik Azma Pars Alborz laboratory scientific Monireh Jalalipour
No. 419, Azadegan Squar, Imam Khomeini Boulevard
Mahdasht Karaj Iran (Islamic Republic of) 3188913179 +98 26 3731 8748 info@naplab.ir Nik Azma Pars Alborz laboratory Iran (Islamic Republic of) Healthy volunteers aged between 18 and 55 years Body mass index less than 30 kg per square meter All candidates must be non-smokers 18 years 55 years Both Blood pressure less than 90 over 60 mm Hg or more than 140 over 90 mm Hg Consumption of any drugs, alcohol or tobacco products within 2 weeks before receiving the drug Other Other Intervention group 1: includes the oral intake of Dapoxetine 60 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blood will be taken from the volunteers at time intervals before the start of drug use and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours after drug use. The cross-over study consists of two phases (oral administration of one 60 mg dapoxetine tablet per study for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Dapoxetine plasma concentration is determined by liquid chromatography mass - spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods. Intervention group 2: includes the oral consumption of 60 mg dapoxetine tablets from Menarini company of England, on 24 healthy fasting volunteers. 5 ml of blood is taken from the volunteers at time intervals before the start of drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours after drug administration. The crossover study consists of two phases (prescribing one 60 mg dapoxetine tablet orally in each study for a total of 2 times) with a one-week washout period (when the drug is completely out of your blood). Dapoxetine plasma concentration is determined by liquid chromatography mass - spectrometry. The analysis of the results will be based on ANOVA and t-test statistical methods. The maximum plasma concentration of dapoxetine. Timepoint: before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24 and 48 hours after taking the drug. Method of measurement: Liquid chromatography-mass spectrometry. Sami Saz Pharmaceutical Company Approved 2023-07-31 Research Institute of Pharmaceutical Sciences, Tehran University of Medical Sciences Institute of Pharmaceutical Sciences, Faculty of Pharmacy, Tehran University of Medical Sciences, Porsina Street Tehran Tehran Iran (Islamic Republic of)