MQX-503 Applied to the Hand Versus Nitroglycerin Ointment Applied to the Chest: A Pharmacokinetic Comparison

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this clinical study is to compare the pharmacokinetic profiles of a topical cream formulation of 0.9% nitroglycerin, MQX 503, and Nitroglycerin Ointment 2%, USP.

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Detailed Description

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Conditions

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Raynaud's Phenomenon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Applied to the hand.

Group Type ACTIVE_COMPARATOR

nitroglycerin 0.9 % (MXQ-503)

Intervention Type DRUG

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

2

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Applied to the chest.

Group Type ACTIVE_COMPARATOR

Nitroglycerin ointment 2%, USP

Intervention Type DRUG

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Interventions

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nitroglycerin 0.9 % (MXQ-503)

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Intervention Type DRUG

Nitroglycerin ointment 2%, USP

MQX-503, topical cream for nitroglycerin 0.9% vs Nitroglycerin ointment 2%, USP.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 to 50 years of age
* Subjects who do not take any prescription medication or who can safely discontinue use prior to visit 1.
* Negative pregnancy test for fertile women and agree to use effective contaception throughout the study.

Exclusion Criteria

* Subjects who can not safely discontinue current prescription medications.
* Subjects who have a known allergy to nitroglycerin or common topical formulation ingredients.
* Subjects with an unstable medical problem.
* Subjects who, within the past three months, have had either a myocardial infarction, uncontrolled congestive heart failure, unstable angina, uncontrolled hypotension, or uncontrolled hypertension.
* Subjects who participated in a study of any investigational drug or device within four weeks prior to Visit 1.
* Subjects who have screening laboratory values which are outside the normal range and which are considered to be clinically significant to the investigator.
* Subjects who have had major abdominal, thoracic, or vascular surgery within six months of Visit 1.
* Subjects with non-epithelialized skin lesions or interfering skin conditions at time of screening in the area where either study medication is to be applied.
* Pregnant or nursing women.
* Women of childbearing potential who are unable or unwilling to comply with the contraceptive requirements during the study period.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes