Bioequivalence Study of Lu AF35700

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Lu AF35700 20 mg clinical formulation; Drug: Lu AF35700 10 mg clinical formulation; Drug: Lu AF35700 5 mg clinical formulation; Drug: Lu AF35700 20 mg commercial formulation; Drug: Lu AF35700 10 mg commercial formulation; Drug: Lu AF35700 5 mg commercial formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03394482

17481A

2017-001335-39 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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87 participants in 6 patient groups

Lu AF35700 5 mg clinical formulation

Experimental group

Treatment:

Drug: Lu AF35700 5 mg clinical formulation

Lu AF35700 5 mg commercial formulation

Experimental group

Treatment:

Drug: Lu AF35700 5 mg commercial formulation

Lu AF35700 10 mg clinical formulation

Experimental group

Treatment:

Drug: Lu AF35700 10 mg clinical formulation

Lu AF35700 10 mg commercial formulation

Experimental group

Treatment:

Drug: Lu AF35700 10 mg commercial formulation

Lu AF35700 20 mg clinical formulation

Experimental group

Treatment:

Drug: Lu AF35700 20 mg clinical formulation

Lu AF35700 20 mg commercial formulation

Experimental group

Treatment:

Drug: Lu AF35700 20 mg commercial formulation