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MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
This study has been completed.
Study NCT00513994   Information provided by MediQuest Therapeutics
First Received: August 7, 2007   Last Updated: April 8, 2008   History of Changes

August 7, 2007
April 8, 2008
August 2007
 
The primary objective is the measurement and comparison of the levels of nitroglycerin and its metabolites in the blood of healthy human volunteers after a single topical dose of MQX-503 and a single topical dose of Nitroglycerin Ointment 2%, USP. [ Time Frame: 8 hours ]
Same as current
Complete list of historical versions of study NCT00513994 on ClinicalTrials.gov Archive Site
A secondary objective is the observation of the volunteers for any adverse events [ Time Frame: 2 weeks ]
Same as current
 
MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects
MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects

The purpose of the study is to measure how much nitroglycerin or its metabolites may be found in the bloodstream when MQX-503 or an FDA approved Nitroglycerin ointment 2% USP is applied to the skin of healthy subjects.

 
Phase I
Interventional
Treatment, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
Healthy
Drug: Nitroglycerin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
6
October 2007
 

Inclusion Criteria:

  • Healthy volunteers 18 - 70 years of age.
  • Subjects able to give written informed consent and comply with study requirements.
  • Subjects willing and able to safely discontinue all current prescription therapies.
  • Subjects who will agree not to participate in other clinical trials.
  • Negative pregnancy test in fertile females and agreement to use effective contraception throughout the study.

Exclusion Criteria:

  • Persons who would be put at risk by discontinuing prescription therapies.
  • Subjects with a known allergy to nitroglycerin.
  • Subjects who have a condition or issue that would adversely affect the application of study medication, study evaluations or the subject's ability to comply with the protocol.
  • Subjects who recently experienced myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension or uncontrolled hypertension.
  • Subjects who have participated in a study of an investigational drug within two weeks of visit 1.
  • Subjects who have screening lab values that are out of range or are considered clinically significant by the investigator.
  • Subjects who have had major abdominal, thoracic, or vascular surgery within 6 months of visit 1.
  • Subjects with non-epithelialized skin lesions or interfering skin conditions at the time of screening in the area where study medication is to be applied.
  • Pregnant or nursing women.
  • Women of childbearing potential who are unwilling to comply with the contraceptive requirements.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00513994
 
07-002
MediQuest Therapeutics
 
Principal Investigator: Adel Nada, M.D. Charles River Clinical Research
MediQuest Therapeutics
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP