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Study aim
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Evaluation of biocompatibility of Ursodeoxycholic acid capsule of Ahran Tejarat Company compared to Ursoflor® on 24 volunteers.
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Design
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Evaluation of single dose of 300 mg Ursodiol capsule made by Ahran Tejarat company in comparison with 300 mg ® Ursoflor capsule of So.Se.PHARM company as a cross-reference product in 24 healthy fasting volunteers
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Settings and conduct
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1 -24 volunteers after their health is confirmed by the project doctor and signed the consent form is submitted to the project.
2 - In the fasting position Ursodiol capsule 300 mg (2) is prescribed with a glass of water (single Dose)
3 - At intervals of 0) before the administration of the drug), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 24, 48, 72 hours after the administration of the drug, blood is taken from the volunteers.
4 - Each volunteer take 2 times the medication at least a week apart.
5 -Isolated plasmas transfer to the analysis laboratory to determine the amount of drug by HPLC method.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: age 18 to 60 years, male, complete clinical health
Exclusion criteria: Underlying diseases, hypertension, kidney, liver and gastrointestinal diseases, smoking and alcohol consumption, chronic drug use and temporary drug use less than 10 days after sampling
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Intervention groups
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Group No. 1 contain healthy volunteer that take the single dose 300 mg capsule Ursodeoxy cholic acid, Ahran Tejarat company as test.
Group No. 2 contain healthy volunteer that take the single dose 300 mg capsule Ursoflor®, So.Se.PHARM company as reference.
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Main outcome variables
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Plasma drug concentration