A Phase 1 interventional study of 0.5 mg Flupentixol film-coated tablet (test treatment) and 1 mg Flupentixol film-coated tablet (test treatment) in Bioequivalence Study in Healthy Subjects, sponsored by H. Lundbeck A/S. Completed at 1 site in Russian Federation. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-26.
Sponsored by H. Lundbeck A/S · Phase 1, Interventional, and Treatment
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
All subjects will be confined to the clinic from Day -1 (Baseline) until Day 6 (120 hours post-dose) for each dosing period. First and second dosing will be separated by a washout period of at least 21 days
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.
Exclusion Criteria:
Other protocol defined inclusion and exclusion criteria may apply
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first test, then reference)
Drug: 0.5 mg Flupentixol film-coated tablet (test treatment) · Drug: 0.5 mg Flupentixol coated tablet (reference treatment)
14 Subjects will receive a 0.5 mg single dose of two different pharmaceutical formulations (first reference, then test)
Drug: 0.5 mg Flupentixol film-coated tablet (test treatment) · Drug: 0.5 mg Flupentixol coated tablet (reference treatment)
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first test, then reference)
Drug: 1 mg Flupentixol film-coated tablet (test treatment) · Drug: 1 mg Flupentixol coated tablet (reference treatment)
14 Subjects will receive a 1 mg single dose of two different pharmaceutical formulations (first reference, then test)
Drug: 1 mg Flupentixol film-coated tablet (test treatment) · Drug: 1 mg Flupentixol coated tablet (reference treatment)
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first test, then reference)
Drug: 5 mg Flupentixol film-coated tablet (test treatment) · Drug: 5 mg Flupentixol coated tablet (reference treatment)
14 Subjects will receive a 5 mg single dose of two different pharmaceutical formulations (first reference, then test)
Drug: 5 mg Flupentixol film-coated tablet (test treatment) · Drug: 5 mg Flupentixol coated tablet (reference treatment)
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
single oral dose, fasted state, day 1 in period 1 or 2
Also known as: Fluanxol®
single oral dose, fasted state, day 1 in period 1 or 2
Also known as: Fluanxol®
single oral dose, fasted state, day 1 in period 1 or 2
Also known as: Fluanxol®
The area under the plasma concentration-time curve
Time frame: from 0 to 72 hours post-dose
The maximum observed concentration (Cmax)
Time frame: from 0 to 72 hours post-dose
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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H. Lundbeck A/S