A Phase 1 interventional study of Idalopirdine 60 mg formulation A (test) and Idalopirdine 60 mg formulation B (reference) in Healthy, sponsored by H. Lundbeck A/S. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-07.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
This study aims to establish bioequivalence between two tablet formulations of idalopirdine
H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Healthy men and women
-≥18 and ≤55 years of age
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
Drug: Idalopirdine 60 mg formulation A (test)
Drug: Idalopirdine 60 mg formulation B (reference)
Tablet for oral use, single dose
Also known as: Lu AE58054
Tablet for oral use, single dose
Also known as: Lu AE58054
Area under the idalopirdine plasma concentration-time curve
Time frame: 0 to 72 hours post-dose
maximum observed concentration (Cmax) of idalopirdine
Time frame: 0 to 72 hours post-dose
This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S