NCT02660840

Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

Interventional, Open-label, Randomised, Crossover, Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations - Film Coated Tablet (Test Treatment) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) and Coated Tablet (Fluanxol®) - 0.5 mg, 1 mg and 5 mg (H. Lundbeck A/S, Denmark) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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

Conditions

• Bioequivalence Study in Healthy Subjects

Interventions

Type	Name	Description
DRUG	0.5 mg Flupentixol film-coated tablet (test treatment)	single oral dose, fasted state, day 1 in period 1 or 2
DRUG	1 mg Flupentixol film-coated tablet (test treatment)	single oral dose, fasted state, day 1 in period 1 or 2
DRUG	5 mg Flupentixol film-coated tablet (test treatment)	single oral dose, fasted state, day 1 in period 1 or 2
DRUG	0.5 mg Flupentixol coated tablet (reference treatment)	single oral dose, fasted state, day 1 in period 1 or 2
DRUG	1 mg Flupentixol coated tablet (reference treatment)	single oral dose, fasted state, day 1 in period 1 or 2
DRUG	5 mg Flupentixol coated tablet (reference treatment)	single oral dose, fasted state, day 1 in period 1 or 2

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-06-01
• First posted: 2016-01-21
• Last updated: 2016-07-26

Locations

1 site across 1 country: Russia