MQX-503 vs Nitroglycerin Ointment: A Pharmacokinetic Comparison in Normal Subjects

This study has been completed.
Sponsor:
Information provided by:
MediQuest Therapeutics
ClinicalTrials.gov Identifier:
NCT00513994
First received: August 7, 2007
Last updated: April 8, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Nitroglycerin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects

Resource links provided by NLM:


Further study details as provided by MediQuest Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • A secondary objective is the observation of the volunteers for any adverse events [ Time Frame: 2 weeks ]

Estimated Enrollment: 6
Study Start Date: August 2007
Study Completion Date: October 2007
Arms Assigned Interventions
Active Comparator: 1 Drug: Nitroglycerin
MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP
Other Name: MQX-503, Nitro-Bid

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513994

Locations
United States, Washington
Charles River Clinical Services
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
MediQuest Therapeutics
Investigators
Principal Investigator: Adel Nada, M.D. Charles River Clinical Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00513994     History of Changes
Other Study ID Numbers: 07-002
Study First Received: August 7, 2007
Last Updated: April 8, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by MediQuest Therapeutics:
Pharmacokinetics
Nitroglycerin
pharmacokinetics study of nitroglycerin containing treatments

Additional relevant MeSH terms:
Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014