Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

January 31, 2016

Primary Completion Date

June 30, 2016

Conditions
Bioequivalence Study in Healthy Subjects
Interventions
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

Trial Locations (1)

Unknown

RU801, Moscow

All Listed Sponsors
lead

H. Lundbeck A/S

INDUSTRY

NCT02660840 - Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations | Biotech Hunter | Biotech Hunter