Status:
COMPLETED
Bioequivalence Study of Lu AF35700
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2018
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT03394482
Start Date
January 3 2018
End Date
October 5 2018
Last Update
November 29 2018
Active Locations (1)
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1
Covance
Leeds, United Kingdom