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OpenTrials
Completed

NCT Number: NCT00513994

MQX-503 vs Nitroglycerin Ointment: 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.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charles River Clinical Services

Tacoma, Washington, 98418, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nitroglycerin

Drug

MQX-503 1%, a topical microemulsion of nitroglycerin 1% and Nitroglycerin Ointment 2%, USP

Other names: MQX-503, Nitro-Bid

Primary outcomes

  1. 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 outcomes

  1. A secondary objective is the observation of the volunteers for any adverse events

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

MediQuest Therapeutics

Industry

Registry information

Official study title

MQX-503 Applied to the Fingers vs. Nitroglycerin Ointment 2%, USP, Applied to the Chest: A Pharmacokinetic Comparison in Normal Subjects

Important dates

Study start
2007
Study completion
2007
First posted
Aug 9, 2007
Registry last updated
Apr 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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