Status:
COMPLETED
Bioequivalence Study to Compare Two Formulations of Deanxit®
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 flupentixol/meltracen, between a new film-coated tablet formulation and the marketed coated tablet formulation (Deanxit®), administered sing...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Healthy men and women ≥18 and ≤55 years of age with a body mass index (BMI) of ≥ 18.5 and ≤ 28 kg/m2.
- Women must be non-pregnant and non-lactating
Exclusion
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03472651
Start Date
May 7 2018
End Date
June 28 2018
Last Update
February 29 2024
Active Locations (1)
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1
CN1036 Shijitan Hospital
Beijing, China