Drug Reactions
Conditions
Brief summary
This study will help determine which types of drugs that may interact with Lu AF35700
Interventions
DRUGLu AF35700
tablets for oral use, 10 mg/day
DRUGMidazolam
syrup for oral use, 4mg/day
Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight at least 50 kg and Body Mass Index 19 - 30 kg/m2 * Good general health ascertained by a detailed medical history, laboratory tests and physical examination
Exclusion criteria
-Pregnant or lactating women Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax: Maximum observed concentration | Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for Cocktail components. | Maximum observed concentration of oral midazolam and all drug cocktail components and their metabolites |
| AUC(0-inf): Area under the plasma concentration-time curve from zero to infinity | Up to 24 hours post dose on the following days: Day 1 and 27 for oral midazolam. Day 2 and 28 for cocktail components. | Area under the plasma concentration-time curve from zero to infinity for oral midazolam and metabolite and all drug cocktail components and their metabolites |
Countries
United Kingdom
Outcome results
None listed