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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® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets [manufactured by Servier (Ireland) Industries Ltd]) in healthy adult volunteers under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERINDOPRES® TRIO (Test) | Experimental | A single oral dose of the test product PERINDOPRES® TRIO 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets. |
|
| TRIPLIXAM® 10 mg /2.5 mg/10 mg | Active Comparator | A single oral dose of the reference product TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine 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), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of perindopril | The Cmax value is 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 value is 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 |
| Cmax of amlodipine | The Cmax value is based on amlodipine plasma concentration. | Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose |
| Area under the concentration-time curve from time zero to 72 hours (AUC0-72) of amlodipine | The AUC0-72 is the area under the plasma concentration versus time curve from time zero (predose) to 72 hours and is based on amlodipine plasma concentration. |
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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 the reference range after being evaluated by the physician as clinically not significant). Haematology tests within 5% of reference limits.
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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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|
| TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine 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), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease). |
|
| Blood sampling for pharmacokinetic analysis covered up to 72 hours post-dose |
| ID | Term |
|---|---|
| C000718378 | perindopril tert-butylamine |
| D007190 | Indapamide |
| D017311 | Amlodipine |
| 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 |
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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