]>
IRCT20130626013776N22 IRCT 2020-07-04 Loghman Company Bioequivalence study of metformin hydrochloride 1000 mg tablets A study to compare the relative bioavailability of Loghman and Merck formulations of metformin 1000 mg tablets in 24 healthy adult male volunteers under fasting conditions 2020-07-22 anticipated 24 Complete https://irct.ir/trial/49300 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Basic scienece, Randomization description: Each subject is identified by a number from 1 to 24. This number is allocated according to their entrance to volunteers' list in the screening day. Then, the following randomization table is used according to the crossover design of the study. All participants randomized into two sequences of Test/Reference and Reference/Test products Subjects Dosing Sequence Day 1 Day 8 1 R/T Reference Test 2 T/R Test Reference 3 T/R Test Reference 4 R/T Reference Test 5 T/R Test Reference 6 R/T Reference Test 7 R/T Reference Test 8 T/R Test Reference 9 T/R Test Reference 10 T/R Test Reference 11 R/T Reference Test 12 R/T Reference Test 13 T/R Test Reference 14 T/R Test Reference 15 T/R Test Reference 16 R/T Reference Test 17 T/R Test Reference 18 R/T Reference Test 19 R/T Reference Test 20 R/T Reference Test 21 T/R Test Reference 22 T/R Test Reference 23 R/T Reference Test 24 R/T Reference Test. Bioequivalence .. Intervention 1: Intervention group: Oral administration of a single 1000 mg dose of metformin hydrochloride (1 tablet) manufactured by Loghman to healthy volunteers under fasting condition in the morning of the experiment day. Intervention 2: Intervention group: Oral administration of a single 1000 mg dose of Glucophage (1 tablet) manufactured by Merck to healthy volunteers under fasting condition in the morning of the experiment day. 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 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) 18-50 years of age. The subject is able and willing to provide signed informed consent. The subject is available for the entire study period and is willing to adhere to protocol requirements as evidenced by written informed consent. The subject has stable residence and telephone. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening. 18 years 50 years Both History of allergy or sensitivity to metformin hydrochloride. 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. 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: Oral administration of a single 1000 mg dose of metformin hydrochloride (1 tablet) manufactured by Loghman to healthy volunteers under fasting condition in the morning of the experiment day Intervention group: Oral administration of a single 1000 mg dose of Glucophage (1 tablet) manufactured by Merck to healthy volunteers under fasting condition in the morning of the experiment day Drug plasma concentration. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC. Area under plasma concentration-time curve. Timepoint: At time zero and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 and 24 h after drug administration. Method of measurement: Blood sampling and measurement of drug concentrations by HPLC. Plasma half-life. Timepoint: From the terminal 16 hours of plasma concentration-time profile. Method of measurement: Blood sampling and drug analysis by HPLC. Loghman Company Approved 2020-05-31 Ethics Committee of Golestan University of Medical Sciences Falsafi Building, Sari Road Km 2 Gorgan Golestan Iran (Islamic Republic of)