Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03282929 | Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD) | PHASE1 | COMPLETED | 43 | — | — | Mar 23, 2017 | Oct 15, 2018 | Jun 21, 2019 | 1 | Germany |
Maximum observed drug concentration
Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.
| Arm | Type | Description |
|---|---|---|
| Part 1 Group 1 | EXPERIMENTAL | A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order. |
| Part 2 group 1 | EXPERIMENTAL | 300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) |
| Part 2 Group 2 | EXPERIMENTAL | 500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) |
| Part 2 Group 3 | EXPERIMENTAL | 300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length) |
| Part 2 Group 4 | EXPERIMENTAL | 300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length) |
| Name | Type | Description |
|---|---|---|
| Part 1 | DEVICE | A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order |
| Part 2 Group 1 | DEVICE | 300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) |
| Part 2 group 2 | DRUG | 500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length) |
| Part 2 group 3 | DEVICE | 300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length) |
| Part 2 Group 4 | DEVICE | 300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length) |
Inclusion Criteria: 1. Healthy male and female subjects, between 18 and 54 years of age (inclusive). 2. Subjects who are able and willing to give written informed consent. 3. Body mass index (BMI) between 28.0 and 40.0 kg/m² (inclusive). Weight on Day -1 may not have changed by more than 3 kg compa...