Trial Outcomes & Findings for Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants (NCT NCT05968482)
NCT ID: NCT05968482
Last Updated: 2025-04-09
Results Overview
Area under the curve (AUC) from time zero to 24 hours
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
Day 7
Results posted on
2025-04-09
Participant Flow
Participant milestones
| Measure |
AMZ001 Low / AMZ001 High / Diclofenac
Participants first received AMZ001 Low dose applied once daily for 7 days (Period 1). After a washout period of at least 21 days, they then received AMZ001 high dose applied once daily for 7 days (Period 2). After another washout period of at least 21 days, they finally received Diclofenac Sodium 1% Gel applied four times daily for 7 days (Period 3). At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
Diclofenac/AMZ001 High/AMZ001 Low
Participants first received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After a washout period of at least 21 days, they then received AMZ001 high dose applied once daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 Low dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
Diclofenac/AMZ001 Low/AMZ001 High
Participants first received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After a washout period of at least 21 days, they then received AMZ001 Low dose applied once daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 high dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
AMZ001 High/AMZ001 Low/Diclofenac
Participants first received AMZ001 High dose applied once daily for 7 days. After a washout period of at least 21 days, they then received AMZ001 low dose applied once daily for 7 days. After another washout period of at least 21 days, they finally received Diclofenac Sodium 1% Gel applied four times daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
AMZ001 Low/Diclofenac/AMZ001 High
Participants first received AMZ001 low dose applied once daily for 7 days. After a washout period of at least 21 days, they then received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 high dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
AMZ001 High/Diclofenac/AMZ001 Low
Participants first received AMZ001 high dose applied once daily for 7 days. After a washout period of at least 21 days, they then received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 low dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
|---|---|---|---|---|---|---|
|
First Crossover Period
STARTED
|
12
|
12
|
12
|
13
|
13
|
12
|
|
First Crossover Period
COMPLETED
|
12
|
12
|
11
|
13
|
13
|
11
|
|
First Crossover Period
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
1
|
|
Second Crossover Period
STARTED
|
12
|
12
|
11
|
13
|
13
|
11
|
|
Second Crossover Period
COMPLETED
|
12
|
12
|
11
|
13
|
12
|
11
|
|
Second Crossover Period
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Third Crossover Period
STARTED
|
12
|
12
|
11
|
13
|
12
|
11
|
|
Third Crossover Period
COMPLETED
|
12
|
11
|
11
|
13
|
11
|
11
|
|
Third Crossover Period
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
AMZ001 Low / AMZ001 High / Diclofenac
Participants first received AMZ001 Low dose applied once daily for 7 days (Period 1). After a washout period of at least 21 days, they then received AMZ001 high dose applied once daily for 7 days (Period 2). After another washout period of at least 21 days, they finally received Diclofenac Sodium 1% Gel applied four times daily for 7 days (Period 3). At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
Diclofenac/AMZ001 High/AMZ001 Low
Participants first received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After a washout period of at least 21 days, they then received AMZ001 high dose applied once daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 Low dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
Diclofenac/AMZ001 Low/AMZ001 High
Participants first received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After a washout period of at least 21 days, they then received AMZ001 Low dose applied once daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 high dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
AMZ001 High/AMZ001 Low/Diclofenac
Participants first received AMZ001 High dose applied once daily for 7 days. After a washout period of at least 21 days, they then received AMZ001 low dose applied once daily for 7 days. After another washout period of at least 21 days, they finally received Diclofenac Sodium 1% Gel applied four times daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
AMZ001 Low/Diclofenac/AMZ001 High
Participants first received AMZ001 low dose applied once daily for 7 days. After a washout period of at least 21 days, they then received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 high dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
AMZ001 High/Diclofenac/AMZ001 Low
Participants first received AMZ001 high dose applied once daily for 7 days. After a washout period of at least 21 days, they then received Diclofenac Sodium 1% Gel applied four times daily for 7 days. After another washout period of at least 21 days, they finally received AMZ001 low dose applied once daily for 7 days. At the end of Period 3, there will be three additional PK blood samples taken respectively at 3 weeks (21 days), 4 weeks (28 days), and 5 weeks (35 days) after the last application to compare elimination phase of AMZ001 vs. Diclofenac Sodium 1% Gel
|
|---|---|---|---|---|---|---|
|
First Crossover Period
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
0
|
0
|
|
First Crossover Period
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Second Crossover Period
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Third Crossover Period
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Third Crossover Period
failure to meet continuation criteria
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Bioavailability and Safety Study Comparing Two Dose Levels of AMZ001 and One Dose Level of Diclofenac Sodium 1% Gel in Healthy Participants
Baseline characteristics by cohort
| Measure |
AMZ001 Low/AMZ001 High/Diclofenac
n=12 Participants
Low/High/Diclofenac
|
Diclofenac/AMZ001 High/AMZ001 Low
n=12 Participants
Diclofenac/High/Low
|
Diclofenac/AMZ001 Low/AMZ001 High
n=12 Participants
Diclofenac/Low/High
|
AMZ001 High/AMZ001 Low/Diclofenac
n=13 Participants
High/Low/Diclofenac
|
AMZ001 Low/Diclofenac/AMZ001 High
n=13 Participants
Low/Diclofenac/High
|
AMZ001 High/Diclofenac/AMZ001 Low
n=12 Participants
High/Diclofenac/Low
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.0 years
STANDARD_DEVIATION 11.20 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 14.69 • n=7 Participants
|
36.4 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 10.60 • n=4 Participants
|
39.8 years
STANDARD_DEVIATION 11.98 • n=21 Participants
|
41.8 years
STANDARD_DEVIATION 13.47 • n=8 Participants
|
41.1 years
STANDARD_DEVIATION 12.69 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
47 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Area under the curve (AUC) from time zero to 24 hours
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Compare Exposure to Diclofenac
|
141.5 ng*hr/mL
Geometric Coefficient of Variation 89.8
|
166.1 ng*hr/mL
Geometric Coefficient of Variation 90.3
|
202.3 ng*hr/mL
Geometric Coefficient of Variation 79.4
|
PRIMARY outcome
Timeframe: Day 1Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Maximum plasma drug concentration (Cmax)
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Cmax
|
4.66 ng/mL
Geometric Coefficient of Variation 122.4
|
6.22 ng/mL
Geometric Coefficient of Variation 128.9
|
3.85 ng/mL
Geometric Coefficient of Variation 122.2
|
SECONDARY outcome
Timeframe: Day 7Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Minimum plasma drug concentration (Cmin)
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Cmin
|
3.09 ng/mL
Geometric Coefficient of Variation 96.3
|
3.38 ng/mL
Geometric Coefficient of Variation 90.1
|
5.03 ng/mL
Geometric Coefficient of Variation 80.1
|
SECONDARY outcome
Timeframe: Day 7Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Time to reach maximum plasma concentration (Tmax)
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Tmax
|
8 hr
Interval 2.0 to 24.0
|
10 hr
Interval 2.0 to 24.0
|
18 hr
Interval 2.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 7Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population. Analysis specified that Ke would be determined whenever the elimination phase after the Day 7 dose appeared to be adequately sampled based on a visual inspection of the log-linear plots.
Terminal disposition rate constant (Ke)
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Ke
|
NA 1/hr
Geometric Coefficient of Variation NA
The PK parameter was not determined because high variability during the elimination phase did not permit linear regression analysis with sufficient confidence. inspection of the individual subject plots of diclofenac concentration vs time post-dose show that the curves are too variable to allow a linear regression analysis.
|
NA 1/hr
Geometric Coefficient of Variation NA
The PK parameter was not determined because high variability during the elimination phase did not permit linear regression analysis with sufficient confidence. inspection of the individual subject plots of diclofenac concentration vs time post-dose show that the curves are too variable to allow a linear regression analysis.
|
NA 1/hr
Geometric Coefficient of Variation NA
The PK parameter was not determined because high variability during the elimination phase did not permit linear regression analysis with sufficient confidence. inspection of the individual subject plots of diclofenac concentration vs time post-dose show that the curves are too variable to allow a linear regression analysis.
|
SECONDARY outcome
Timeframe: Day 7Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Average plasma concentration (Cavg)
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Cavg
|
5.90 ng/mL
Geometric Coefficient of Variation 89.8
|
6.92 ng/mL
Geometric Coefficient of Variation 90.3
|
8.43 ng/mL
Geometric Coefficient of Variation 79.4
|
SECONDARY outcome
Timeframe: Day 1Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Time to reach maximum plasma concentration
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Tmax
|
14 hr
Interval 2.0 to 24.0
|
16 hr
Interval 4.0 to 24.0
|
20 hr
Interval 6.0 to 24.0
|
SECONDARY outcome
Timeframe: Day 1Population: All subjects for which at least AUC0-τ or Cmax can be determined for the reference treatment (Diclofenac Sodium 1% Gel) along with at least one of Treatments AMZ001 Low dose or AMZ001 High dose are included in the analysis population.
Average plasma concentration (Cavg)
Outcome measures
| Measure |
AMZ001 Low Dose
n=69 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=69 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=69 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Pharmacokinetic Parameter - Cavg
|
2.59 ng/mL
Geometric Coefficient of Variation 119.8
|
3.48 ng/mL
Geometric Coefficient of Variation 124.8
|
1.60 ng/mL
Geometric Coefficient of Variation 109.9
|
SECONDARY outcome
Timeframe: Day 1 to Day 7Population: The Safety population includes randomized subjects who received at least one dose of AMZ001 Low dose or High dose or Diclofenac Sodium 1% Gel
Incidence of application site reactions according to the terminology of the International Contact Dermatitis Research Group
Outcome measures
| Measure |
AMZ001 Low Dose
n=71 Participants
AMZ001 Low dose received either during Period 1, Period 2 or Period 3
|
AMZ001 High Dose
n=72 Participants
AMZ001 High dose received either during Period 1, Period 2 or Period 3
|
Diclofenac Sodium 1% Gel
n=72 Participants
Reference product applied four-times daily for 7 consecutive days received either in Period 1, Period 2 or Period 3
|
|---|---|---|---|
|
Local Tolerability
no skin reaction
|
62 Participants
|
61 Participants
|
64 Participants
|
|
Local Tolerability
doubtful skin reaction
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Local Tolerability
mild skin erythema
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Local Tolerability
strong skin erythema
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
AMZ001 Low Dose
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
AMZ001 High Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Diclofenac Sodium 1% Gel
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AMZ001 Low Dose
n=71 participants at risk
AMZ001 applied once daily for 7 consecutive days
Diclofenac Sodium Gel: Topical application on both knees
|
AMZ001 High Dose
n=72 participants at risk
AMZ001 applied once daily for 7 consecutive days
Diclofenac Sodium Gel: Topical application on both knees
|
Diclofenac Sodium 1% Gel
n=72 participants at risk
Reference product applied four-times daily for 7 consecutive days
Diclofenac Sodium Gel: Topical application on both knees
|
|---|---|---|---|
|
General disorders
Administration site dermatitis
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Injury, poisoning and procedural complications
Contusion / abrasion
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.8%
2/71 • Number of events 2 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
General disorders
Administration site dryness
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
General disorders
Administration site pruritus
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
General disorders
Application site dermatitis
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
General disorders
Application site erythema
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
4.2%
3/72 • Number of events 3 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
General disorders
Application site hypersensitivity
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
2.8%
2/72 • Number of events 2 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
General disorders
Application site pruritus
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Gastrointestinal disorders
Dry mouth
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Nervous system disorders
Headache
|
2.8%
2/71 • Number of events 2 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/71 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratinosis
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.4%
1/71 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
1.4%
1/72 • Number of events 1 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
0.00%
0/72 • From initiation of first period (Day 1) to completion of last period (Day 98)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Master Service agreement: Work Product shall be and remain the sole and exclusive property of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER