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

NCT ID: NCT00513994

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Pharmacokinetics Nitroglycerin pharmacokinetics study of nitroglycerin containing treatments

Study Design

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Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Nitroglycerin

Intervention Type DRUG

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

Interventions

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Nitroglycerin

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

Intervention Type DRUG

Other Intervention Names

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MQX-503, Nitro-Bid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MediQuest Therapeutics

INDUSTRY

Sponsor Role lead

Principal Investigators

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Adel Nada, M.D.

Role: PRINCIPAL_INVESTIGATOR

Charles River Clinical Research

Locations

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Charles River Clinical Services

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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07-002

Identifier Type: -

Identifier Source: org_study_id