Bioequivalence Clinical Trial
Official title:
Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 10 mg Commercial Tablet (Test) to the 10 mg Clinical Tablet (Reference)
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
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | GB1050 | Leeds |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | Maximum observed concentration of idalopirdine (Cmax) | baseline to 72 hours post-dose | No | |
Secondary | Time to occurrence of Cmax (tmax) | baseline to 72 hours post-dose | No | |
Secondary | Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity | baseline to 72 hours post-dose | No | |
Secondary | Apparent elimination half-life (t1/2) | baseline to 72 hours post-dose | No |
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