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| Name | Class |
|---|---|
| International Pharmaceutical Research Center | OTHER |
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The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (PERINDOPRES® DUO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product Noliterax® 10 mg /2.5 mg, 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERINDOPRES® DUO (Test) | Experimental | A single oral dose of the test product PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets. |
|
| Noliterax® 10 mg/2.5 mg (Reference) | Active Comparator | A single oral dose of the reference product Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERINDOPRES® DUO 8 mg perindopril tert-butylamine / 2.5 mg indapamide tablets | Drug | Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of perindopril | The Cmax values are based on perindopril plasma concentration. | Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose |
| Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-t) of perindopril | The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on perindopril plasma concentration. | Blood sampling for pharmacokinetic analysis covered up to 36 hours post-dose |
| Cmax of indapamide | The Cmax values are based on indapamide plasma concentration. | Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose |
| AUC0-t of indapamide | The AUC0-t is the area under the plasma concentration versus time curve from time zero (predose) to time of last quantifiable concentration (t) and is based on indapamide plasma concentration. | Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose |
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Inclusion Criteria:
Healthy subjects, age 18 to 50 years, inclusive, body mass index (BMI) range is within 18.5 - 30.0 kg/m2, subject does not have a known allergy to the drug under investigation or any of its ingredients or any other related drugs, standard ECG assessment is normal (no QTc prolongation), medical history and physical examination within medically acceptable criteria, laboratory investigations tests within laboratory reference ranges (ALP and creatinine are accepted if below 5% of the reference range). Haematology tests within 5% of reference limits, the subject is willing to adhere to the protocol requirement throughout the study and to provide written informed consent.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Pharmaceutical Research Center | Amman | 11196 | Jordan |
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Two-period, two-sequence, cross-over single dose study
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|
| Noliterax® 10 mg/2.5 mg 10 mg perindopril arginine / 2.5 mg indapamide film-coated tablets | Drug | Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure) and indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) |
|
| ID | Term |
|---|---|
| C000718378 | perindopril tert-butylamine |
| D007190 | Indapamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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