Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn - Tabular View

Tracking Information
First Received Date ^ICMJE	October 4, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00006330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn
Official Title ^ICMJE
Brief 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.
Detailed Description
Study Phase
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Placebo Control, Crossover Assignment
Condition ^ICMJE	Heart Diseases
Intervention ^ICMJE	Drug: Digoxin Drug: Hawthorn
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00006330
Responsible Party
Study ID Numbers ^ICMJE	NCRR-M01RR00042-1693, M01RR00042
Study Sponsor ^ICMJE	National Center for Research Resources (NCRR)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Center for Research Resources (NCRR)
Verification Date	November 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP