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IRCT20130626013776N70 IRCT 2022-07-19 Pars Behrouzan Jam Pharmaceuticals Bioequivalence study of doxycycline hyclate 100 mg capsules A study to compare the relative bioavailability of Pars Behrouzan Jam and Mylan tablet formulations of doxycycline hyclate 100 mg in 24 healthy adult volunteers under fasting conditions 2022-10-23 anticipated 24 Complete https://irct.ir/trial/64628 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: A pot sampling method will be used in this study. 12 papers are labeled "Reference Product" and 12 papers are written as "Test Product". The papers are then placed in sealed envelopes, and participants randomly select a paper and will be placed in the Reference or Test groups. Bioequivalence .. Intervention 1: Intervention group 1: Oral administration of a single 100 mg dose of doxycycline hyclate (1 capsule) manufactured by Pars Behrouzan Jam to healthy volunteers under fasting conditions in the morning of the experiment day. Intervention 2: Intervention group 2: Oral administration of a single 100 mg dose of doxycycline hyclate (1 capsule) manufactured by Mylan to healthy volunteers under fasting conditions in the morning of the experiment day. No - There is not a plan to make this available Justification or reason for not sharing IPD is Data are confidential and need permission from the company.
public Hossein Amini
Sari Road, Km 2
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3252 5972 haminhplc@yahoo.com Gorgan University of Medical Sciences scientific Hossein Amini
Sari Road, Km 2
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3252 5972 haminhplc@yahoo.com Gorgan University of Medical Sciences Iran (Islamic Republic of) 18-55 years of age. The subject is able and willing to provide signed informed consent. The subject is available for the entire study period. Willing to adhere to protocol requirements as evidenced by written informed consent. The subject has a stable residence and telephone. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. 18 years 55 years Both History of allergy or sensitivity to doxycycline. History of any drug hypersensitivity or intolerance which, in the opinion of the investigator,would compromise the safety of the subject of the study. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction. Presence of gastrointestinal disease or history of malabsorption within the last year. History of a medical disorders occurring within the last year that required hospitalization or medication. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing. Receipt of any drug as part of a research study within 30 days prior to the present study. Donation or significant loss of whole blood (480 ml or more) within 30 days prior to the present study. Treatment - Drugs Treatment - Drugs Intervention group 1: Oral administration of a single 100 mg dose of doxycycline hyclate (1 capsule) manufactured by Pars Behrouzan Jam to healthy volunteers under fasting conditions in the morning of the experiment day Intervention group 2: Oral administration of a single 100 mg dose of doxycycline hyclate (1 capsule) manufactured by Mylan to healthy volunteers under fasting conditions in the morning of the experiment day Drug plasma concentration. Timepoint: At time zero and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 24, 48 and 72 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by high-performance liquid chromatography. Plasma half-life. Timepoint: From the terminal 60 hours of plasma concentration-time profile. Method of measurement: Blood sampling and drug analysis by high-performance liquid chromatography method. Pars Behrouzan Jam Pharmaceuticals Approved 2022-07-03 Ethics Committee of Golestan University of Medical Sciences Falsafi Building, Sari Road Km 2 Gorgan Golestan Iran (Islamic Republic of)