Meta AnalysisID 513
健康成人中钙通道阻滞剂与葡萄柚汁的相互作用 [Cochrane方案]
CRD42015022014
To evaluate whether and to what extent grapefruit juice interacts with individual calcium channel blockers in healthy adults.
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Record Fields
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- Meta Analysis Id
- 513
- Evidence Id
- 9071
- Core Evidence Id
- 9071
- Source Meta Analysis Id
- 486
- Herb2 Meta Analysis Id
- HBMA000486
- Crd Id
- CRD42015022014
- Title
- Interaction of calcium channel blockers and grapefruit juice in healthy adults [Cochrane Protocol]
- Review Question
- To evaluate whether and to what extent grapefruit juice interacts with individual calcium channel blockers in healthy adults.
- Study Type Included
- We will include randomized controlled clinical trials.
- Condition Being Studied
- The Cochrane Hypertension Group
- Participant
- Adults (aged > 18 years) of either sex diagnosed as healthy by either history, medical examination and/or laboratory examination, irrespective of ethnic group.
- Animal
- Human Disease Modelled
- Intervention
- Comparison: calcium channel blockers with and without grapefruit juice. We will include those trials in which calcium channel blocker is administered either with or without grapefruit juice. Trials that have evaluated other interventions in addition to these two arms will also be included and only the data from those relevant arms will be considered for review. We will also include cross-over trials wherein the same participant receives both the intervention and the comparison with a wash out period of at least seven days. We will include studies irrespective of the dose and duration of grapefruit juice as well as the formulation, chemical entity, dose and duration of calcium channel blockers, and irrespective of whichever is administered first. Only those trials that have evaluated the drug concentration using a standard pharmacokinetic method will be included.
- Comparator Control
- Calcium channel blockers with and without grapefruit juice.
- Main Outcome
- <ol> Area under concentration-time curve (AUC <sub>0-t</sub> and AUC<sub>0-∞</sub>) which is a measure of rate and extent of absorption of a drug. Maximum concentration achieved in the plasma (C<sub>max</sub>) following a dose of calcium channel blocker. Time to achieve the maximum concentration of calcium channel blocker in the plasma (T<sub>max</sub>). </ol>
- Outcome Measure
- Additional Outcome
- <ol> Elimination half life (t<sub>1/2</sub>) - time taken for the drug concentration to reduce to half of its initial value. Clearance (CL) of the drug that represents the volume of plasma or blood that is completely cleared of the drug in a unit time. Volume of distribution (V<sub>d</sub>) of the drug which is an apparent volume that contains the drug in the same concentration as that of blood. Absorption rate constant (k<sub>a</sub>) of the drug. Change in heart rate. Change in blood pressure. Flushing. Headache. </ol>
- Study Method
- Keyword
- Adult; Calcium Channel Blockers; Citrus paradisi; Food-Drug Interactions; Humans
- Contact
- Sridharan Kannan [email protected]
- Organisational Affiliation
- The Cochrane Collaboration http://www.cochrane.org/
- Funding Source
- Seth GS Medical College and KEM Hospital, Mumbai
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- India
- Review Stage
- Review Ongoing
- First Submission Date
- Registration Date
- 2015-05-29
- Anticipated Start Date
- 2014-12-15
- Anticipated Completion Date
- 2016-12-15
- Title Cn
- 健康成人中钙通道阻滞剂与葡萄柚汁的相互作用 [Cochrane方案]
- Title En
- Interaction of calcium channel blockers and grapefruit juice in healthy adults [Cochrane Protocol]
- Bilingual Status
- complete