At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 50 years (inclusive) at screening
- ✓BMI between 18.5 and 29.9 kg/m² (inclusive)
- ✓Body weight ≥50 kg
- ✓Normal medical history, vital signs, physical exam, ECG, and laboratory tests (or deviations not clinically significant per PI)
- ✕Psychiatric disorder, antagonistic personality, poor motivation, or emotional/intellectual problems affecting consent validity or protocol compliance
- ✕Alcohol consumption >21 units/week for males or >14 units/week for females
- ✕Regular substance abuse exposure (other than alcohol) in past year
- ✕Use of any medication (especially diclofenac or other NSAIDs) or herbal remedies within 2 weeks before first IMP administration, except hormonal contraceptives
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Diclofenac Sodium, Diclofenac & Capsaicin, and 1 other intervention for Healthy. Completed, enrolled 48 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
twice daily
twice daily
twice daily