Trials Sponsors Conditions Drugs Pricing

Conditions

Bioequivalence

Outcome Measures

Primary Outcomes (1)

Blood and tissue diclofenac concentrations
Blood and tissue concentrations (nanograms/milliliter) of the drug diclofenac will be measured and compared between different batches of the product Flector. In addition, the two batches will be compared at different application sites, namely the abdomen and thigh. Tissue concentrations will be measured using microdialysis.
24 hours per visit

Study Arms (4)

Reference, Patch location thigh, batch 1

EXPERIMENTAL

Reference, Patch location thigh, batch 1: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug.

Drug: Reference, Patch location thigh, batch 1

Test, Patch location thigh, batch 2

EXPERIMENTAL

Test, Patch location thigh, batch 2: A single dose of the patch will be applied. In addition, the Microdialysis probe consisting of three probes will be inserted to test for the amount of the drug diclofenace. This will determine whether the site of application affects the availability of the drug.

Device: Test, Patch location thigh, batch 2

Reference, Patch location abdomen, batch 1

Interventions

Reference, Patch location thigh, batch 1Drug

Reference, Patch location thigh, batch 1

Also known as: Flector patch

Reference, Patch location thigh, batch 1

Test, Patch location thigh, batch 2Device

Test, Patch location thigh, batch 2. Three probes will be inserted at each visit.

Also known as:

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Males or females, between 18 and 55 years of age.
Body mass index of 18.5 and 32 kg/m2, inclusive.

Sponsors & Collaborators

Food and Drug Administration (FDA)
US federal agencycollaborator
University of Florida
Otherlead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Study Officials

Hartmut Derendorf, PhD
University of Florida
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 30, 2012

First Posted

May 4, 2012

Study Start

April 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Clinically significant abnormal values for hematology or chemistry at screening.
History of current significant medical illness including (but not limited to) cardiovascular thrombotic events, myocardial infarction, stroke or other cardiac disease, hypertension, peptic ulcer disease or gastrointestinal bleeding, skin disorders, hematological disease, bronchospastic respiratory disease, asthma, diabetes mellitus, renal or hepatic insufficiency, or any other illness that the investigator considers should exclude the subject.
History of atopic eczema, dry skin or ichthyosis.
Excessive hair at the site of application that could possibly affect drug absorption; scar tissue, open tissue(s), tattoo or coloration that would interfere with the test sites, their assessments, and their reaction to drug, or that may compromised the safety of the subjects.
Known allergies or hypersensitivity to Flector® Patch or diclofenac-containing products.
Clinically significant abnormal physical examination and/or vital signs (e.g. systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg, heart rate \>100 bpm and \<45 bpm).
Received an investigational drug (including vaccines) within 60 days prior to study drug administration or are currently enrolled in an investigational study.
Pregnant or breast-feeding.
Recent history of surgery; within the past 3 months prior to screening.
Clinically significant acute illness within 7 days prior to study drug administration.
Donation of 1 or more units (approximately 450 mL) of blood or acute loss of an equivalent amount of blood within 60 days prior to study drug administration.
Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Over-the-counter or prescription use of other non-steroidal anti-inflammatory drug products.

Clinical Study to Evaluate the Role of Microdialysis for the Comparison of Topical Products

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Reference, Patch location thigh, batch 1

Test, Patch location thigh, batch 2

Reference, Patch location abdomen, batch 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Test, Patch location abdomen, batch 2

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (4)

Reference, Patch location thigh, batch 1

Test, Patch location thigh, batch 2

Reference, Patch location abdomen, batch 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

Test, Patch location abdomen, batch 2

You may not qualify if:

Source record

Locations