Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Diseases
Intervention: Digoxin (Drug); Hawthorn (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR)
Summary
Hawthorn (Crataegus oxyacantha) is a natural product that is popular in European and American
herbal medicine practice. Some of its cardiac uses include the treatment of high and low
blood pressure, rapid heart beat, chest pain, and blocked arteries. In many cases, it is
used as an adjuvant agent with other cardiac drugs such as digoxin, amiodarone, and warfarin.
To date, little information is known about the effect of hawthorn when taken with other
drugs and if toxicities occur when hawthorn is used with other drugs. The purpose of this
study is to examine the interaction between digoxin and hawthorn in eight healthy subjects.
Subjects will be recruited by advertisement. The design of the study will include a 10-day
and a three-week treatment phase of digoxin 0. 125 mg - 0. 25 mg/day and hawthorn (Crataegus
special extract WS1442, Schwabe Co.) 450 mg twice daily or placebo, with a randomized
crossover. There will be a three-week washout period in between treatment phases. On day 10
(phase I) and day 21 (phase II), subjects will have 12 blood samples drawn for
pharmacokinetic analysis. The plasma samples will be measured for digoxin concentration.
Additionally, the subjects will be assessed for any clinical toxicities or adverse events.
The significance of this study is to provide the clinician with information regarding the
safe use of digoxin in combination with the herbal supplement, hawthorn.
Clinical Details
Study design: Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy adult
- Not regularly taking any prescription or non-prescription medications (including
natural products or supplements) and is willing to avoid all medications other than
the study drugs during the study period.
- Willing to avoid drinking any alcohol throughout the study period.
- Does not currently smoke and is willing to avoid smoking during the study period.
- Willing to adhere to dietary restrictions as required during the study.
Locations and Contacts
Univ. of Michigan Medical Center, Ann Arbor, Michigan 48109-0008, United States
Additional Information
Last updated: June 23, 2005
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