A Phase 1 interventional study of Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet in Bioequivalence, sponsored by Pharmtechnology LLC. Status unknown at 1 site in Russia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Pharmtechnology LLC · Phase 1, Interventional, and Other
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Triplixam®, 10 mg/2.5 mg/10 mg tablets) or the test (Perindopril Erbumine/ 8 mg/2.5 mg/10 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, 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 Perindopril/ Indapamide/Amlodipine 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 54 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 oral dose of perindopril/amlodipine/indapamide (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, after which a standardized lunch will be served. Next meals will be provided for subjects in 4 hours, 8 hours and 12 hours after drug administration.
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 29 blood samples will be collected (one tube of 5-10 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.
Perindopril, perindoprilate, amlodipine plasma concentrations and indapamide whole blood concentrations will be measured according to a validated bioanalytical method.
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 perindopril, perindoprilate, amlodipine and indapamide 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-t should all be within the 80.00 to 125.00% bioequivalence range.
Pharmtechnology LLC is the lead sponsor of 27 studies on the registry; 1 is open to participants now.
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For female subject:
Exclusion Criteria:
25 subjects assigned to the sequence TR will receive a single oral dose of the test product Perindopril Erbumine/Indapamide/Amlodipine (1 x 8 mg/2.5 mg/10 mg tablet), marked as T in the sequence, in Period 1 and a single oral dose of the reference product Triplixam® (1 x 10 mg/2.5 mg/10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
Drug: Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet
25 subjects assigned to the sequence RT will receive a single oral dose of the reference product Triplixam® (1 x 10 mg/2.5 mg/10 mg tablet), marked as R in the sequence, in Period 1 and a single oral dose of the test product Perindopril Erbumine/Amlodipine/Indapamide (1 x 8 mg/2.5 mg/10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
Drug: Perindopril/Indapamide/Amlodipine 8 mg/2.5 mg/10 mg tablet / Triplixam® 10 mg/2.5 mg/10 mg tablet
Perindopril/Indapamide/Amlodipine is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 8 mg of perindopril erbumine, 2.5 mg of indapamide and 10 mg of amlodipine. Triplixam® is manufactured by Les Laboratoires Servier Industrie, France. Each tablet contains 10 mg of perindopril arginine, 2.5 mg of indapamide and 10 mg of amlodipine.
Also known as: The test product / The reference product
Cmax of perindopril after administration of the test and the reference products.
Maximum observed concentration in plasma.
Time frame: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.
Cmax of active metabolite perindoprilat of the test and the reference products
Maximum observed concentration in plasma.
Time frame: Time points for perindoprilat 0.00 (prior to each drug administration) and 0.30, 1.00, 1.30, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 5.30, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cmax of indapamide of the test and the reference products
Maximum observed concentration in plasma.
Time frame: Time points for indapamide 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Cmax of amlodipine of the test and the reference products
Maximum observed concentration in plasma.
Time frame: Time points for amlodipine 0.00 (prior to each drug administration) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of perindopril of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Time frame: Time points for perindopril 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 12.00, 24.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of active metabolite perindoprilat of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Time frame: Time points for perindoprilat 0.00 (prior to each drug administration) and 0.30, 1.00, 1.30, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 5.30, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of indapamide of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Time frame: Time points for indapamide 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 6.00, 8.00, 10.00, 12.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
AUC0-72 of amlodipine of the test and reference products
Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.
Time frame: Time points for amlodipine 0.00 (prior to each drug administration) and 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after each drug administration.
Tmax of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time of maximum observed concentration. if it occurs at more than one time point, Tmax is defined as the first time point with this value.
Time frame: Up to 72 hours
TLQC of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Time of last observed quantifiable concentration.
Time frame: Up to 72 hours
AUC0-INF of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Area under the concentration time curve extrapolated to infinity, calculated as AUC0-t + ĈLQC (the predicted concentration at time TLQC) / λZ (apparent elimination rate constant).
Time frame: Up to 72 hours
Residual area of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Extrapolated area (i.e. percentage of AUC0-INF due to extrapolation from TLQC to infinity).
Time frame: Up to 72 hours
Time point where the log-linear elimination phase begins (TLIN) of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood
Time point where the log-linear elimination phase begins.
Time frame: Up to 72 hours
λZ of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Apparent elimination rate constant, estimated by linear regression of the terminal linear portion of the log concentration versus time curve.
Time frame: Up to 72 hours
Terminal elimination half-life (Thalf) of perindopril, perindoprilat, amlodipine in plasma and indapamide in whole blood after administration of the test and the reference products.
Terminal elimination half-life, calculated as ln(2)/λZ.
Time frame: Up to 72 hours
Number of treatment-emergent adverse events for the test and the reference products.
The safety population will include all subjects who received at least one dose of the test or the reference product. Any significant changes will be recorded as treatment-emergent adverse events only if they are judged clinically significant by the qualified investigator or delegate.
Time frame: Up to 54 days
Started Jun 2023 (actual). Primary completion is estimated for Aug 2023, 1 month after the start.
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