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Bioequivalence Study of Lu AF35700

NCT03394482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2018-11-29

No results posted yet for this study

Summary

The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

Conditions

  • Healthy

Interventions

DRUG

Lu AF35700 5 mg clinical formulation

Lu AF35700 tablets 5 mg oral single dose

DRUG

Lu AF35700 5 mg commercial formulation

Lu AF35700 tablets 5 mg oral single dose

DRUG

Lu AF35700 10 mg clinical formulation

Lu AF35700 tablets 10 mg oral single dose

DRUG

Lu AF35700 10 mg commercial formulation

Lu AF35700 tablets 10 mg oral single dose

DRUG

Lu AF35700 20 mg clinical formulation

Lu AF35700 tablets 20 mg oral single dose

DRUG

Lu AF35700 20 mg commercial formulation

Lu AF35700 tablets 20 mg oral single dose

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
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-03
Primary Completion
2018-10-05
Completion
2018-10-05

Countries

  • United Kingdom

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 NCT03394482 on ClinicalTrials.gov