NCT03394482

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-01-03
• Primary completion: 2018-10-05
• Completion: 2018-10-05
• First posted: 2018-01-09
• Last updated: 2018-11-29

Locations

1 site across 1 country: United Kingdom