Bioequivalence
Conditions
Brief summary
The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market
Interventions
DRUGIdalopirdine commercial tablet (test)
single dose, 10 mg, oral
DRUGIdalopirdine clinical tablet (reference)
single dose, 10 mg, oral
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy men and women with a body mass index (BMI) of \>18.5 and \<30 kg/m2.
Exclusion criteria
* pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose | baseline to 72 hours post-dose |
| Maximum observed concentration of idalopirdine (Cmax) | baseline to 72 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Time to occurrence of Cmax (tmax) | baseline to 72 hours post-dose |
| Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity | baseline to 72 hours post-dose |
| Apparent elimination half-life (t1/2) | baseline to 72 hours post-dose |
Countries
United Kingdom
Outcome results
None listed