Healthy Clinical Trial
Official title:
A SINGLE CENTER, MULTIPLE DOSE, OPEN-LABEL, RANDOMIZED, THREE-PERIOD CROSSOVER STUDY TO DETERMINE THE RELATIVE BIOAVAILABILITY OF DICLOFENAC IN THE TOPICAL GEL COMBINATION PRODUCT (DICLOFENAC 2% + CAPSAICIN 0.075%) COMPARED TO DICLOFENAC MONO GEL 2% AND VOLTAROL® 12 HOUR EMULGEL 2.32% GEL IN AT LEAST 42 HEALTHY MALES AND FEMALES
The main objective of this study is to assess the relative systemic bioavailability of
diclofenac in the presence and absence of capsaicin by comparing the systemic bioavailability
of diclofenac from a combination product (Diclofenac 2% + Capsaicin 0.075% Topical Gel) with
two diclofenac only products, Diclofenac Mono Gel 2% and Voltarol® 12 Hour Emulgel 2.32% Gel,
following topical administration.
In order to examine potential racial differences in pharmacokinetics (PK), the study
population will be stratified 50:50, Caucasian versus Black people. With respect to the main
objective, additionally a supportive analysis will be performed to investigate the influence
of race on the intra-individual bioavailability ratios.
n/a
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