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Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations

NCT02660840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-07-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-06-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02660840 on ClinicalTrials.gov