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Influence of grape juice and orange juice on the pharmacokinetics and pharmacodynamics of diltiazem in healthy human male subjects.

Identifieur interne : 000A20 ( PubMed/Corpus ); précédent : 000A19; suivant : 000A21

Influence of grape juice and orange juice on the pharmacokinetics and pharmacodynamics of diltiazem in healthy human male subjects.

Auteurs : T. Ahmed ; M. Sajid ; T. Singh ; G S Saini ; T. Monif ; N. Saha ; K K Pillai

Source :

RBID : pubmed:18826865

English descriptors

Abstract

The objective was to study the effect of grape juice and orange juice on the pharmacokinetics (PK) and pharmacodynamics (PD) of diltiazem in healthy human volunteers.

PubMed: 18826865

Links to Exploration step

pubmed:18826865

Le document en format XML

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<title xml:lang="en">Influence of grape juice and orange juice on the pharmacokinetics and pharmacodynamics of diltiazem in healthy human male subjects.</title>
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<name sortKey="Ahmed, T" sort="Ahmed, T" uniqKey="Ahmed T" first="T" last="Ahmed">T. Ahmed</name>
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<nlm:affiliation>Department of Metabolism and Pharmacokinetics, Ranbaxy Research Laboratories, Gurgaon, India. drtarandeep@gmail.com</nlm:affiliation>
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<name sortKey="Sajid, M" sort="Sajid, M" uniqKey="Sajid M" first="M" last="Sajid">M. Sajid</name>
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<name sortKey="Singh, T" sort="Singh, T" uniqKey="Singh T" first="T" last="Singh">T. Singh</name>
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<name sortKey="Saini, G S" sort="Saini, G S" uniqKey="Saini G" first="G S" last="Saini">G S Saini</name>
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<name sortKey="Monif, T" sort="Monif, T" uniqKey="Monif T" first="T" last="Monif">T. Monif</name>
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<name sortKey="Saha, N" sort="Saha, N" uniqKey="Saha N" first="N" last="Saha">N. Saha</name>
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<name sortKey="Pillai, K K" sort="Pillai, K K" uniqKey="Pillai K" first="K K" last="Pillai">K K Pillai</name>
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<title xml:lang="en">Influence of grape juice and orange juice on the pharmacokinetics and pharmacodynamics of diltiazem in healthy human male subjects.</title>
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<term>Blood Pressure (drug effects)</term>
<term>Calcium Channel Blockers (administration & dosage)</term>
<term>Calcium Channel Blockers (pharmacokinetics)</term>
<term>Calcium Channel Blockers (pharmacology)</term>
<term>Capsules</term>
<term>Chromatography, High Pressure Liquid</term>
<term>Citrus sinensis</term>
<term>Cross-Over Studies</term>
<term>Delayed-Action Preparations</term>
<term>Diltiazem (administration & dosage)</term>
<term>Diltiazem (pharmacokinetics)</term>
<term>Diltiazem (pharmacology)</term>
<term>Drug Administration Schedule</term>
<term>Food-Drug Interactions</term>
<term>Heart Rate (drug effects)</term>
<term>Humans</term>
<term>Male</term>
<term>Vitis</term>
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<term>Calcium Channel Blockers</term>
<term>Diltiazem</term>
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<term>Blood Pressure</term>
<term>Heart Rate</term>
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<keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en">
<term>Calcium Channel Blockers</term>
<term>Diltiazem</term>
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<keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en">
<term>Calcium Channel Blockers</term>
<term>Diltiazem</term>
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<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Area Under Curve</term>
<term>Beverages</term>
<term>Capsules</term>
<term>Chromatography, High Pressure Liquid</term>
<term>Citrus sinensis</term>
<term>Cross-Over Studies</term>
<term>Delayed-Action Preparations</term>
<term>Drug Administration Schedule</term>
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<div type="abstract" xml:lang="en">The objective was to study the effect of grape juice and orange juice on the pharmacokinetics (PK) and pharmacodynamics (PD) of diltiazem in healthy human volunteers.</div>
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<Year>2008</Year>
<Month>10</Month>
<Day>1</Day>
</DateCreated>
<DateCompleted>
<Year>2009</Year>
<Month>05</Month>
<Day>18</Day>
</DateCompleted>
<DateRevised>
<Year>2013</Year>
<Month>11</Month>
<Day>21</Day>
</DateRevised>
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<ISSN IssnType="Print">0946-1965</ISSN>
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<Volume>46</Volume>
<Issue>10</Issue>
<PubDate>
<Year>2008</Year>
<Month>Oct</Month>
</PubDate>
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<Title>International journal of clinical pharmacology and therapeutics</Title>
<ISOAbbreviation>Int J Clin Pharmacol Ther</ISOAbbreviation>
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<ArticleTitle>Influence of grape juice and orange juice on the pharmacokinetics and pharmacodynamics of diltiazem in healthy human male subjects.</ArticleTitle>
<Pagination>
<MedlinePgn>511-8</MedlinePgn>
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<Abstract>
<AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">The objective was to study the effect of grape juice and orange juice on the pharmacokinetics (PK) and pharmacodynamics (PD) of diltiazem in healthy human volunteers.</AbstractText>
<AbstractText Label="METHODOLOGY" NlmCategory="METHODS">The study design was open-label, balanced, randomized, 3-period, single-dose and crossover. A group of 12 healthy, adult, male human volunteers received a single oral dose of diltiazem 180 mg extended release capsule on three different occasions: with 200 ml of water, with 200 ml of grape juice and with 200 ml of orange juice in random order. A washout period of 7 days was kept between each study period. Serial blood samples were collected up to 24 h post dose and assayed for diltiazem using a specific and validated HPLC method. Blood pressure (BP) and ECG measurements were done at 0, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 h post dose. Analysis of variance was carried out using logarithmic transformations of AUC and Cmax as well as nontransformed tmax.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">No significant change was observed in heart rate and BP. The median tmax was identical in all three occasions. The 90% CI of the Cmax ratios for orange juice/water were 104.59 - 114.86 and for grape juice/water were 93.91 - 103.13. Similarly, the 90% CI of the AUC0-inf ratios for orange juice and grape juice vs. water were 103.68 - 119.83 and 88.56 - 104.06, respectively. Since these values fall within the bioequivalence criteria of 80 - 120% limits, our study demonstrates absence of interaction of diltiazem with grape juice or orange juice.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">There is no significant influence of grape juice or orange juice on the pharmacokinetics and pharmacodynamics of diltiazem.</AbstractText>
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