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Pharmacokinetic and Pharmacodynamic Interaction Study of Digoxin and Hawthorn

This study has been completed.
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006330
First received: October 4, 2000
Last updated: June 23, 2005
Last verified: November 2001
History of Changes
  Purpose

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.


Condition Intervention
Heart Diseases
 Drug: Digoxin
Drug: Hawthorn

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Digoxin
U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006330

Locations
United States, Michigan
Univ. of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-0008
Sponsors and Collaborators
National Center for Research Resources (NCRR)
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006330     History of Changes
Other Study ID Numbers: NCRR-M01RR00042-1693, M01RR00042
Study First Received: October 4, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
Digoxin
Effect modifiers (Epidemiology)
Rosales
Drug Interaction

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013