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IRCT20230222057495N9 IRCT 2023-08-19 Sami Saz Pharmaceutical Company Bioequivalence study of bisoprolol fumarate hydrochlorothiazide tablet 10/25 mg Bioequivalence study of bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz pharmaceutical company compared to samples of bisoprolol fumarate 10 mg from Merck Germany and hydrochlorthiazide 25 mg from Juvise France on healthy volunteers 2023-08-11 anticipated 24 Complete https://irct.ir/trial/71814 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 bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 fasting healthy volunteers. 5 ml of blood was taken from the volunteers at time intervals before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the drug. can be The cross-over study consists of two phases (oral administration of one tablet of bisoprolol fumarate hydrochlorothiazide 10.25 mg per study and a total of 2 times) with a one-week washout period (when the drug is completely removed from your blood). . Determination of plasma concentration of bisoprolol fumarate and hydrochlorothiazide is done 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 intake of bisoprolol fumarate 10 mg tablets from Merck, Germany and hydrochlorthiazide 25 mg from Juvise, France on 24 healthy fasting volunteers. 5 ml of blood was taken from the volunteers at time intervals before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the drug. can be The cross-over study consists of two phases (oral administration of one tablet of bisoprolol fumarate hydrochlorothiazide 10.25 mg per study and a total of 2 times) with a one-week washout period (when the drug is completely removed from your blood). . Determination of plasma concentration of bisoprolol fumarate and hydrochlorothiazide is done by liquid chromatography mass-spectrometry method. 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 Square, 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 on 60 mm Hg or more than 140 on 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 bisoprolol fumarate hydrochlorothiazide 10.25 mg tablets of Sami Saz Pharmaceutical Company of Iran on 24 fasting healthy volunteers. 5 ml of blood was taken from the volunteers at time intervals before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the drug. can be The cross-over study consists of two phases (oral administration of one tablet of bisoprolol fumarate hydrochlorothiazide 10.25 mg per study and a total of 2 times) with a one-week washout period (when the drug is completely removed from your blood). . Determination of plasma concentration of bisoprolol fumarate and hydrochlorothiazide is done 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 intake of bisoprolol fumarate 10 mg tablets from Merck, Germany and hydrochlorthiazide 25 mg from Juvise, France on 24 healthy fasting volunteers. 5 ml of blood was taken from the volunteers at time intervals before starting to take the drug and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the drug. can be The cross-over study consists of two phases (oral administration of one tablet of bisoprolol fumarate hydrochlorothiazide 10.25 mg per study and a total of 2 times) with a one-week washout period (when the drug is completely removed from your blood). . Determination of plasma concentration of bisoprolol fumarate and hydrochlorothiazide is done by liquid chromatography mass-spectrometry method. The analysis of the results will be based on ANOVA and t-test statistical methods. Maximum plasma concentrations of bisoprolol fumarate and hydrochlorothiazide. Timepoint: Before taking the medicine and: 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 7, 9, 10, 24, 34 and 48 hours after taking the medicine. 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)