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

Sponsored by:	MediQuest Therapeutics
Information provided by:	MediQuest Therapeutics
ClinicalTrials.gov Identifier:	NCT00513994

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study
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:

Drug Information available for: Nitroglycerin

U.S. FDA Resources

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

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

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

Keywords provided by MediQuest Therapeutics:

Pharmacokinetics
Nitroglycerin
pharmacokinetics study of nitroglycerin containing treatments

Study placed in the following topic categories:

Nitroglycerin
Vasodilator Agents
Cardiovascular Agents
Healthy

Additional relevant MeSH terms:

Nitroglycerin
Vasodilator Agents
Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009