Bioequivalence Study of Lu AF35700

Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03394482

Enrollment

Registered

2018-01-09

Start date

2018-01-03

Completion date

2018-10-05

Last updated

2018-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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

Interventions

DRUGLu AF35700 5 mg clinical formulation

Lu AF35700 tablets 5 mg oral single dose

DRUGLu AF35700 5 mg commercial formulation

Lu AF35700 tablets 5 mg oral single dose

DRUGLu AF35700 10 mg clinical formulation

Lu AF35700 tablets 10 mg oral single dose

DRUGLu AF35700 10 mg commercial formulation

Lu AF35700 tablets 10 mg oral single dose

DRUGLu AF35700 20 mg clinical formulation

Lu AF35700 tablets 20 mg oral single dose

DRUGLu AF35700 20 mg commercial formulation

Lu AF35700 tablets 20 mg oral single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy men and women aged ≥18 and ≤55 years * Body Mass Index (BMI) of ≥18.5 and ≤32 kg/m2 * Subject must be in good general health as assessed using medical history, clinical laboratory tests, and physical examination

Exclusion criteria

* The subject must not be of childbearing potential (if a woman) or should use contraception, be surgically sterilized or not be sexually active (both sexes). Women must not be pregnant or lactating * The subject must not be a CYP2D6 or a CYP2C19 poor metaboliser * The subject has previously been dosed with Lu AF35700 Other protocol defined inclusion and

Design outcomes

Primary

Measure	Time frame	Description
AUC0-72h of Lu AF35700	zero to 72 hours	Area under the Lu AF35700 plasma concentration-time curve from zero to 72 hours post-dose (AUC0-72h)
Cmax of Lu AF35700	zero to 72 hours	Maximum observed plasma concentration (Cmax) of Lu AF35700

Secondary

Measure	Time frame	Description
Tmax of Lu AF35700	zero to 72 hours	Time to occurance of Cmax of Lu AF35700
AUC0-t of Lu AF35700	zero to time of the last quantifiable plasma concentration	Area under the Lu AF35700 concentration-time curve from zero to time of the last quantifiable plasma concentration

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026