Trial Outcomes & Findings for Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days. (NCT NCT06729073)
NCT ID: NCT06729073
Last Updated: 2026-01-06
Results Overview
Area under the curve from time zero to 24 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Day 7
Results posted on
2026-01-06
Participant Flow
Participant milestones
| Measure |
AMZ001/Diclofenac Diethylamine 1.16%
AMZ001 applied once daily for 7 consecutive days followed by at least 21-day washout followed by Diclofenac diethylamine 1.16% applied four times daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%/AMZ001
Reference product applied four-times daily for 7 consecutive days followed by at least 21-day washout followed by AMZ001 applied once daily for 7 consecutive days
|
|---|---|---|
|
1
STARTED
|
17
|
17
|
|
1
COMPLETED
|
17
|
17
|
|
1
NOT COMPLETED
|
0
|
0
|
|
2
STARTED
|
17
|
16
|
|
2
COMPLETED
|
17
|
16
|
|
2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Diclofenac Systemic Exposure From Two Different Products (AMZ001 and Diclofenac Diethylammonium 1.16% Gel) in Healthy Participants After Repeated Topical Administrations for 7 Days.
Baseline characteristics by cohort
| Measure |
AMZ001/Diclofenac Diethylamine 1.16%
n=17 Participants
AMZ001 applied once daily for 7 consecutive days followed by at least 21-day washout followed by Diclofenac diethylamine 1.16% applied four times daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%/AMZ001
n=17 Participants
Reference product applied four-times daily for 7 consecutive days followed by at least 21-day washout followed by AMZ001 applied once daily for 7 consecutive days
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.2 years
STANDARD_DEVIATION 12.75 • n=37 Participants
|
44.5 years
STANDARD_DEVIATION 9.94 • n=56 Participants
|
45.8 years
STANDARD_DEVIATION 11.34 • n=82 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=37 Participants
|
7 Participants
n=56 Participants
|
18 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=37 Participants
|
10 Participants
n=56 Participants
|
16 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=37 Participants
|
15 Participants
n=56 Participants
|
32 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
1 Participants
n=56 Participants
|
1 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=37 Participants
|
17 Participants
n=56 Participants
|
34 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Day 7Area under the curve from time zero to 24 hours
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Area Under the Curve 0-24h
|
281.60 h*ng/mL
Geometric Coefficient of Variation 67.1
|
411.35 h*ng/mL
Geometric Coefficient of Variation 57.2
|
SECONDARY outcome
Timeframe: Day 7Minimum plasma drug concentration (Cmin)
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Pharmacokinetic Parameter - Cmin
|
5.812 ng/mL
Geometric Coefficient of Variation 73.1
|
10.22 ng/mL
Geometric Coefficient of Variation 50.2
|
SECONDARY outcome
Timeframe: Day 7Average plasma concentration (Cavg)
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Pharmacokinetic Parameter - Cavg
|
11.733 ng/mL
Geometric Coefficient of Variation 67.1
|
17.139 ng/mL
Geometric Coefficient of Variation 57.2
|
SECONDARY outcome
Timeframe: Day 7Time to reach maximum plasma concentration (Tmax)
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Pharmacokinetic Parameter - Tmax
|
6 h
Interval 0.0 to 20.017
|
17.9830 h
Interval 0.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 1Area under the curve from time zero to 24 hours and maximum (peak) plasma drug concentration
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Compare Exposure to Diclofenac
|
141.76 h*ng/mL
Geometric Coefficient of Variation 101.6
|
86.76 h*ng/mL
Geometric Coefficient of Variation 116.3
|
SECONDARY outcome
Timeframe: Day 1Time to reach maximum plasma concentration (Tmax)
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Pharmacokinetic Parameter - Tmax
|
9.9170 h
Interval 4.0 to 23.833
|
23.8330 h
Interval 8.0 to 23.883
|
SECONDARY outcome
Timeframe: Day 1Average plasma concentration
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Pharmacokinetic Parameter - Cavg
|
5.906 ng/mL
Geometric Coefficient of Variation 101.6
|
3.615 ng/mL
Geometric Coefficient of Variation 116.3
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Number of subjects having at least one event
Outcome measures
| Measure |
AMZ001
n=33 Participants
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 Participants
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Incidence of Application Site Reactions
|
0 Participants
|
1 Participants
|
Adverse Events
AMZ001
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Diclofenac Diethylamine 1.16%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AMZ001
n=33 participants at risk
AMZ001 applied once daily for 7 consecutive days
|
Diclofenac Diethylamine 1.16%
n=34 participants at risk
Reference product applied four-times daily for 7 consecutive days
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
6.1%
2/33 • From enrollment until end of treatment period 2
|
8.8%
3/34 • From enrollment until end of treatment period 2
|
|
Infections and infestations
Rhinitis
|
0.00%
0/33 • From enrollment until end of treatment period 2
|
2.9%
1/34 • From enrollment until end of treatment period 2
|
|
Infections and infestations
Urinary tract infection
|
3.0%
1/33 • From enrollment until end of treatment period 2
|
0.00%
0/34 • From enrollment until end of treatment period 2
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • From enrollment until end of treatment period 2
|
5.9%
2/34 • From enrollment until end of treatment period 2
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.0%
1/33 • From enrollment until end of treatment period 2
|
0.00%
0/34 • From enrollment until end of treatment period 2
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/33 • From enrollment until end of treatment period 2
|
2.9%
1/34 • From enrollment until end of treatment period 2
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/33 • From enrollment until end of treatment period 2
|
2.9%
1/34 • From enrollment until end of treatment period 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
1/33 • From enrollment until end of treatment period 2
|
0.00%
0/34 • From enrollment until end of treatment period 2
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/33 • From enrollment until end of treatment period 2
|
2.9%
1/34 • From enrollment until end of treatment period 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place