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IRCT20200105046010N1 IRCT 2020-04-12 Cobel Darou Pharmaceutical Company Levetiracetam tablet 1000mg (LEVEBEL 1000mg, Cobel Darou) In- Vivo Bioequivalence study in Iranian healthy volunteers In- Vivo Bioequivalence study of Levetiracetam tablet 1000mg Cobel Darou (LEVEBEL 1000mg) with brand drugs (KEPPRA 1000mg UCB Pharma, Belgium) in Iranian healthy volunteers 2020-02-19 anticipated 24 Complete https://irct.ir/trial/44776 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: Two periode / Two sequence with a washout time, Randomization description: Individuals are randomly selected with advertising 24 volunteers categorized in two sequences randomly.the type of drug (Sample and Brand drug) will prescribe with lottery, Blinding description: Candidates are not aware of the test drug or brand name. Bioequivalence in this study the bioequivalence of test and brand of levetiracetam will evaluated.. Crossover study with two intervention groups. Intervention group A (Sequence 1, volunteers 1-12) and intervention group B (sequence 2, volunteers 13-24) without control group based on the guidelines of FDA for bioequivalence study. intervention parameters including: type & dose of the drug, type of dosage form, sampling intervals,sample preparation method, feeding or fasting conditions, analytical method and individual differences between subjects. single dose, randomized, double blind, two ways, two periods study.. No - There is not a plan to make this available Justification or reason for not sharing IPD is These data are as secure between researcher and related industries
public Javad Shokri
Tabriz University of Medical Sciences, Faculty of Pharmacy
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 shokri.j@gmail.com Tabriz University of Medical Sciences scientific Javad shokri
Tabriz University Faculty of Pharmacy
Tabriz Iran (Islamic Republic of) 5166414766 +98 41 3334 8489 shokri.j@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) General health (liver & heart & kidney ) Body mass index (18-25) Informed consent Age (18-60 ) 18 years 55 years Both Smoking A history of cardiovascular disease A history of Liver & Kidney disease Pregnancy Alcohol & Drug addiction Hypersensitivity Other Crossover study with two intervention groups. Intervention group A (Sequence 1, volunteers 1-12) and intervention group B (sequence 2, volunteers 13-24) without control group based on the guidelines of FDA for bioequivalence study. intervention parameters including: type & dose of the drug, type of dosage form, sampling intervals,sample preparation method, feeding or fasting conditions, analytical method and individual differences between subjects. single dose, randomized, double blind, two ways, two periods study. Drug analysis in plasma or whole blood. Timepoint: After blood sampling. Method of measurement: HPLC, LC-MS/MS or UPLC-MS/MS. Cobel Darou Pharmaceutical Company Approved 2020-01-20 Tabriz University of Medical Sciences ethics committe No. 48, Ferdows street, Ferdowsi Sq. Tabriz East Azarbaijan Iran (Islamic Republic of)