IRCT20230222057495N5 IRCT 2023-06-05 Chemidarou Pharmaceutical Company Bioequivalence study of 300 mg ursodeoxycholic acid capsules Bioequivalence study of 300 mg ursodeoxycholic acid capsule of Kimidaro Pharmaceutical Company compared to 300 mg ursodeoxycholic acid of Aurobindo Pharma LTD, India on healthy volunteers 2023-05-22 anticipated 24 Complete https://irct.ir/trial/70192 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Other. Bioequivalence In the present study, no disease was investigated.. Intervention 1: Intervention group 1: includes the oral consumption of two 300 mg ursodeoxycholic acid capsules manufactured by Kimidarou Pharmaceutical Company of Iran on 24 healthy fasting volunteers. 5 ml of blood at intervals of one and a half hours before drug administration and: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration. It is taken from volunteers. The cross-over study consists of two phases (oral consumption of two 300 mg ursodeoxycholic acid capsules per study and 2 times in total) with a four-week washout period (when the drug is completely removed from your blood). Determining the plasma concentration of urosodeoxycholic acid is done by liquid chromatography-mass spectrometry. 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 two capsules of ursodeoxycholic acid 300 mg manufactured by Aurobindo Pharma LTD in India on 24 healthy fasting volunteers. 5 ml of blood at intervals of one and a half hours before drug administration and: 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12 and 24 hours after administration. It is taken from volunteers. The cross-over study consists of two phases (oral consumption of two 300 mg ursodeoxycholic acid capsules per study and 2 times in total) with a four-week washout period (when the drug is completely removed from your blood). Determining the plasma concentration of urosodeoxycholic acid is done 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