Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects
AIM: The bioavailability of two 300 mg irbesartan (CAS 138402-11-6)/12.5 mg hydrochlorothiazide (CAS 58-93-5) tablet formulations was compared, using Co-Ir-vell tablets as test formulation and the originator product as reference formulation.
METHODS: Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover study following an overnight fasting. A two-week wash-out period was applied. Blood samples were drawn up to 48 h following drug administrations. Irbesartan and hydrochlorothiazide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t), AUC(0-infinity), Cmax and t were determined and used for bioequivalence evaluation after log-transformation, whereas t max ratios were evaluated non-parametrically.
RESULTS: The estimated point and 90% confidence intervals (CI) for AUC(0-t), AUC(0-infinity), Cmax and t for irbesartan were 97.74% (85.40-111.86%), 96.36% (83.25-111.55%), 103.30% (90.65-117.71%), 92.38% (82.68-103.21%) and for hydrochlorothiazide, 106.30% (97.72-115.63%), 106.28% (98.14-115.10%), 108.01% (95.48-122.18%), 105.52% (96.70-115.14%), respectively.
CONCLUSION: These results indicated that the two formulations of irbesartan/hydrochlorothiazide were bioequivalent; therefore they may be prescribed interchangeably.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2010 |
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| Erschienen: |
2010 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:60 |
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| Enthalten in: |
Arzneimittel-Forschung - 60(2010), 12 vom: 30., Seite 749-53 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Sasongko, Lucy [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 03.03.2011 Date Revised 01.12.2018 published: Print Citation Status MEDLINE |
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| doi: |
10.1055/s-0031-1296350 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM205341888 |
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| 100 | 1 | |a Sasongko, Lucy |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Comparative bioavailability of two irbesartan/hydrochlorothiazide tablet formulations in Indonesian healthy subjects |
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| 500 | |a Date Completed 03.03.2011 | ||
| 500 | |a Date Revised 01.12.2018 | ||
| 500 | |a published: Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a AIM: The bioavailability of two 300 mg irbesartan (CAS 138402-11-6)/12.5 mg hydrochlorothiazide (CAS 58-93-5) tablet formulations was compared, using Co-Ir-vell tablets as test formulation and the originator product as reference formulation | ||
| 520 | |a METHODS: Twenty-four subjects were included in this single-dose, open-label, randomized two-way crossover study following an overnight fasting. A two-week wash-out period was applied. Blood samples were drawn up to 48 h following drug administrations. Irbesartan and hydrochlorothiazide plasma concentrations were determined by liquid chromatography-tandem mass spectrometry method with TurboIonSpray mode. Pharmacokinetic parameters AUC(0-t), AUC(0-infinity), Cmax and t were determined and used for bioequivalence evaluation after log-transformation, whereas t max ratios were evaluated non-parametrically | ||
| 520 | |a RESULTS: The estimated point and 90% confidence intervals (CI) for AUC(0-t), AUC(0-infinity), Cmax and t for irbesartan were 97.74% (85.40-111.86%), 96.36% (83.25-111.55%), 103.30% (90.65-117.71%), 92.38% (82.68-103.21%) and for hydrochlorothiazide, 106.30% (97.72-115.63%), 106.28% (98.14-115.10%), 108.01% (95.48-122.18%), 105.52% (96.70-115.14%), respectively | ||
| 520 | |a CONCLUSION: These results indicated that the two formulations of irbesartan/hydrochlorothiazide were bioequivalent; therefore they may be prescribed interchangeably | ||
| 650 | 4 | |a Comparative Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 7 | |a Angiotensin II Type 1 Receptor Blockers |2 NLM | |
| 650 | 7 | |a Antihypertensive Agents |2 NLM | |
| 650 | 7 | |a Biphenyl Compounds |2 NLM | |
| 650 | 7 | |a Diuretics |2 NLM | |
| 650 | 7 | |a Drug Combinations |2 NLM | |
| 650 | 7 | |a Tetrazoles |2 NLM | |
| 650 | 7 | |a Hydrochlorothiazide |2 NLM | |
| 650 | 7 | |a 0J48LPH2TH |2 NLM | |
| 650 | 7 | |a Irbesartan |2 NLM | |
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| 700 | 1 | |a Harahap, Yahdiana |e verfasserin |4 aut | |
| 700 | 1 | |a Prasaja, Budi |e verfasserin |4 aut | |
| 700 | 1 | |a Lusthom, Windy |e verfasserin |4 aut | |
| 700 | 1 | |a Setiawan, Evy C |e verfasserin |4 aut | |
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