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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014