Trial Outcomes & Findings for A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects (NCT NCT04683926)
NCT ID: NCT04683926
Last Updated: 2023-04-04
Results Overview
The AUC(0-32) and AUC(inf) of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.
Results posted on
2023-04-04
Participant Flow
Participant milestones
| Measure |
A-B-D-C
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
B-C-A-D
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
C-D-B-A
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
D-A-C-B
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
|---|---|---|---|---|
|
Intervention 1 (1 Day)
STARTED
|
6
|
6
|
6
|
6
|
|
Intervention 1 (1 Day)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Intervention 1 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 1 (3 Days)
STARTED
|
6
|
6
|
6
|
6
|
|
Washout 1 (3 Days)
COMPLETED
|
6
|
6
|
6
|
6
|
|
Washout 1 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention 2 (1 Day)
STARTED
|
6
|
6
|
6
|
6
|
|
Intervention 2 (1 Day)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Intervention 2 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Washout 2 (3 Days)
STARTED
|
6
|
6
|
6
|
5
|
|
Washout 2 (3 Days)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Washout 2 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention 3 (1 Day)
STARTED
|
6
|
6
|
6
|
5
|
|
Intervention 3 (1 Day)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Intervention 3 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout 3 (3 Days)
STARTED
|
6
|
6
|
6
|
5
|
|
Washout 3 (3 Days)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Washout 3 (3 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention 4 (1 Day)
STARTED
|
6
|
6
|
6
|
5
|
|
Intervention 4 (1 Day)
COMPLETED
|
6
|
6
|
6
|
5
|
|
Intervention 4 (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
A-B-D-C
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
B-C-A-D
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
C-D-B-A
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
D-A-C-B
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
|---|---|---|---|---|
|
Intervention 2 (1 Day)
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Randomized Study Investigating Oral Desmetramadol Dose Proportionality and Food Effect In Normal Human Subjects
Baseline characteristics by cohort
| Measure |
A-B-D-C
n=6 Participants
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
B-C-A-D
n=6 Participants
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
C-D-B-A
n=6 Participants
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
D-A-C-B
n=6 Participants
Treatments A, B, C and D given in the order indicated, wherein A is desmetramadol 3 x 10 mg tablets, fed; B is desmetramadol 3 x 10 mg tablets, fasted; C is desmetramadol 2 x 10 mg tablets, fasted; and D is desmetramadol 1 x 10 mg tablets, fasted. Treatments given with 240 ml water and separated by 3 days washout. Fasted treatments comprise a 10 hour fast before and 4 hours after treatment administration. Fed treatment is given 30 minutes after a standard meal.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
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
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 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
|
|
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
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.Population: Evaluable population. The evaluable population are those subjects with calculable values for one or more of AUC0-inf (AUC0-t when appropriate) and/or Cmax.
The AUC(0-32) and AUC(inf) of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
Outcome measures
| Measure |
Desmetramadol 10 mg, Fasted
n=24 Participants
While fasting a single oral dose of 10 mg desmetramadol under.
Desmetramadol: Analgesic
|
Desmetramadol 20 mg, Fasted
n=23 Participants
While fasting a single oral dose of 20 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg, Fasted
n=23 Participants
While fasting a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg, Fed
n=23 Participants
After feeding a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
|---|---|---|---|---|
|
(-/+)-M1, AUC(0-32) and AUC(Inf)
AUC(0-32), (-/+)-M1
|
136.0 ng*hr/mL
Standard Deviation 30.5
|
274.9 ng*hr/mL
Standard Deviation 61.3
|
408.8 ng*hr/mL
Standard Deviation 86.0
|
450.7 ng*hr/mL
Standard Deviation 103.6
|
|
(-/+)-M1, AUC(0-32) and AUC(Inf)
AUC(inf), (-/+)-M1
|
138.0 ng*hr/mL
Standard Deviation 31.1
|
279.0 ng*hr/mL
Standard Deviation 62.1
|
414.6 ng*hr/mL
Standard Deviation 87.8
|
454.4 ng*hr/mL
Standard Deviation 105.4
|
PRIMARY outcome
Timeframe: Pre-dose (0 h), and post-dose 0.5, 1.0, 1.5, 2.0, 2.5, 3.0 ,3.5, 4, 6, 8, 12, 16, 24, and 32 h.Population: Evaluable population. The evaluable population are those subjects with calculable values for one or more of AUC0-inf (AUC0-t when appropriate) and/or Cmax.
The Cmax of (-/+)-M1 after each treatment (i.e., 10, 20 and 30 mg desmetramadol fasted, and 30 mg desmetramadol fed)
Outcome measures
| Measure |
Desmetramadol 10 mg, Fasted
n=24 Participants
While fasting a single oral dose of 10 mg desmetramadol under.
Desmetramadol: Analgesic
|
Desmetramadol 20 mg, Fasted
n=23 Participants
While fasting a single oral dose of 20 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg, Fasted
n=23 Participants
While fasting a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg, Fed
n=23 Participants
After feeding a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
|---|---|---|---|---|
|
(-/+)-M1, Cmax
|
12.41 ng/mL
Standard Deviation 2.59
|
24.22 ng/mL
Standard Deviation 5.08
|
36.27 ng/mL
Standard Deviation 7.47
|
43.42 ng/mL
Standard Deviation 10.73
|
SECONDARY outcome
Timeframe: Participant report adverse events throughout study enrolment; investigators observe adverse events during all 11 days of inpatient treatment; laboratory safety labs are obtained on Day 11 (the final study day).Population: Only treatment-emergent AEs (TEAEs) are summarized. A TEAE is defined as an AE that is starting or worsening at the time of or after study drug dosing. Each TEAE will be attributed to a treatment based on the onset date and time of the AE. An AE that occurs during the washout period between drugs will be considered treatment-emergent to the last drug administered prior to onset of the AE. See "Adverse Events" for data table.
Adverse events will include: 1) reports by participants; 2) observations by investigators; and 3) abnormal laboratory safety test results.
Outcome measures
| Measure |
Desmetramadol 10 mg, Fasted
n=24 Participants
While fasting a single oral dose of 10 mg desmetramadol under.
Desmetramadol: Analgesic
|
Desmetramadol 20 mg, Fasted
n=23 Participants
While fasting a single oral dose of 20 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg, Fasted
n=23 Participants
While fasting a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg, Fed
n=23 Participants
After feeding a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment.
|
3 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
Adverse Events
Desmetramadol 10 mg, Fasted
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Desmetramadol 20 mg, Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Desmetramadol 30 mg , Fasted
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Desmetramadol 30 mg , Fed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Desmetramadol 10 mg, Fasted
n=24 participants at risk
While fasting a single oral dose of 10 mg desmetramadol under.
Desmetramadol: Analgesic
|
Desmetramadol 20 mg, Fasted
n=23 participants at risk
While fasting a single oral dose of 20 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg , Fasted
n=23 participants at risk
While fasting a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
Desmetramadol 30 mg , Fed
n=23 participants at risk
After feeding a single oral dose of 30 mg desmetramadol.
Desmetramadol: Analgesic
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
Eye disorders
Periorbital swelling
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
Gastrointestinal disorders
Constipation
|
4.2%
1/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
1/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
8.7%
2/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
4.2%
1/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
General disorders
Fatigue
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
8.7%
2/23 • 11 days.
|
|
General disorders
Feeling abnormal
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
General disorders
Localised oedema
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/24 • 11 days.
|
4.3%
1/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/24 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
13.0%
3/23 • 11 days.
|
8.7%
2/23 • 11 days.
|
|
Nervous system disorders
Headache
|
0.00%
0/24 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/24 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Nervous system disorders
Tremor
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
1/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
1/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/24 • 11 days.
|
0.00%
0/23 • 11 days.
|
0.00%
0/23 • 11 days.
|
4.3%
1/23 • 11 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor shall retain title to and the right to publish all documentation, records, raw data, specimens or other work product generated in connection with the performance of the Services. Such publications shall not be made by Celerion without the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER