Bioequivalence Clinical Trial
Official title:
Open-label With Blinding Bioanalytical Stage Randomized Crossover Two Period Two Sequences Single Dose Bioequivalence Study of Two Formulations Ramipril/Hydrochlorothiazide Tablets 10 mg/25 mg (Manufacturer: Pharmtechnology LLC, Republic of Belarus) and Tritace® Plus Tablets 10 mg/25 mg (Manufacturer: Sanofi S.p.A., Italy; Holder of the Registration Certificate: Sanofi-Aventis Deutschland GmbH, Germany) in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, with blinding bioanalytical stage, randomized, two period, two sequences, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace® Plus, 10 mg/25 mg tablets) or the test (Ramipril/Hydrochlorothiazide, 10 mg/25 mg tablets) formulation in each period of study (sequences Test-Reference (TR) or Reference-Test (RT)), in order to evaluate if both formulations are bioequivalent.
This is an open-labeled, with blinding bioanalytical stage, randomized, two period, crossover, a single-center, comparative, single-dose study, in which 50 healthy adult subjects will receive one of the study treatments during each study period. The objective of this study is to determine the bioequivalence of two different formulations of combination ramipril/hydrochlorothiazide after a single oral dose administration under fasting conditions. Subject eligibility for this study will be determined at the screening visit and eligible subjects will be admitted to the clinical research unit at least 12 hours prior to drug administration for each study period. Hospitalization in the first period of the study will last no more than 36 hours, after which, in the absence of indications for an extension of hospitalization, each subject will be released home; after that, the first period of the study will be completed. The procedures of the second study period will be identical to the first period. After completing all the procedures of the second study period, each subject will undergo a final examination, after which, in case of the absence of adverse events and indications for prolonging hospitalization, the study for the subjects will be considered completed. The total duration of the study for the subject will be no more than 46 days. Eligible subjects will be randomized to one of two treatment sequences. There will be two sequences in the study: TR and RT, where T = the test product, R = the reference product. For each study period, subjects will receive a single 10 mg/25 mg oral dose of ramipril/hydrochlorothiazide (the test or the reference formulation). Study participants will be aware they will receive different formulations of the same drug, without being informed which product (Test or Reference) is being administered. For each subject, all scheduled postdose activities and assessments will be performed relative to the time of study drug administration. Fasting will continue for at least 4 hours following drug administration. Breakfast will be organized 4 hours after taking the drug, lunch after 8 hours, dinner after 12 hours. Water will be provided as needed until 1 hour predose. Water will be allowed beginning 2 hours after the administration of the drug. A total of 24 blood samples will be collected (one tube of 6 mL each) in each study period for pharmacokinetic (PK) assessments. The first blood sample will be collected prior to drug administration while the others will be collected up to 72 hours after drug administration. The concentration of ramipril, ramiprilat and hydrochlorothiazide will be determined using high performance liquid chromatography with mass spectrometric detection according to a method developed and validated in the analytical laboratory. Statistical analysis of all PK parameters will be based on an ANOVA model. Two-sided 90% confidence interval of the ratio of geometric LSmeans obtained from the ln-transformed PK parameters will be calculated. Statistical inference of ramipril, ramiprilat and hydrochlorothiazide will be based on a bioequivalence approach using the following standards: the ratio of geometric LSmeans with corresponding 90% confidence interval calculated from the exponential of the difference between the Test and the Reference for the ln-transformed parameters Cmax and AUC0-72 should all be within the 80.00 to 125.00% bioequivalence range. ;
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