A Phase 1 interventional study of Idalopirdine commercial tablet (test) and Idalopirdine clinical tablet (reference) in Bioequivalence, sponsored by H. Lundbeck A/S. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-11.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
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
H. Lundbeck A/S is the lead sponsor of 224 studies on the registry; 9 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.
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Exclusion Criteria:
Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days
Drug: Idalopirdine commercial tablet (test) · Drug: Idalopirdine clinical tablet (reference)
Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days
Drug: Idalopirdine commercial tablet (test) · Drug: Idalopirdine clinical tablet (reference)
single dose, 10 mg, oral
single dose, 10 mg, oral
Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose
Time frame: baseline to 72 hours post-dose
Maximum observed concentration of idalopirdine (Cmax)
Time frame: baseline to 72 hours post-dose
Time to occurrence of Cmax (tmax)
Time frame: baseline to 72 hours post-dose
Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity
Time frame: baseline to 72 hours post-dose
Apparent elimination half-life (t1/2)
Time frame: baseline to 72 hours post-dose
The record gives a start of Sep 2016, a primary completion of Sep 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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