Study in Healthy Subjects to Compare Two Tablet Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions

Healthy Clinical Trial

Official title:

Interventional, Randomized, Single-dose, Open-label, Crossover, Bioequivalence Study in Healthy Subjects to Compare Two Pharmaceutical Formulations of Memantine (Ebixa®) in Fasted and Fed Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03670095
• Other study ID #: 17773A
• Status: Completed
• Phase: Phase 1
• Start date: August 28, 2018
• Est. completion date: December 24, 2018

Study information

• Verified date: February 2024
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the release of memantine into the bloodstream of two different formulations: one formulation containing lactose and one without lactose.

Description:

The study consists of two cohorts: A1 and A2. Subjects in Cohort A1 will be administered the investigational medicinal product (IMP) in a fasted state and subjects in Cohort A2 will be administered the IMP in a fed state. Each subject will change cohort during study participation, so that dosing will be done over two periods: either first fed and then fasted, or first fasted and then fed. The two periods will be separated by a period of 28 days (+7 days) where no investigational medicinal product is given. All subjects will be confined to the clinic from one day prior to dosing until Day 4 (72 hours post-dose) in each dosing period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 24, 2018
• Est. primary completion date: December 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy men and women =18 years of age with a body mass index (BMI) =18.5 and =28 kg/m2.
• Women must be non-pregnant and non-lactating.

Exclusion Criteria:

• The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP. Other in- and exclusion criteria may apply

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Lactose-free memantine
Lactose-free memantine tablet, 10 mg; orally as a single dose
• Memantine
Lactose-containing memantine tablet, 10 mg, orally as a single dose

Locations

Country	Name	City	State
China	Shuguang Hospital, Shanghai TCM University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-72h in fed state for test and reference treatment	Area under the memantine plasma concentration-time curve	From zero to 72 hours post dose
Primary	AUC0-72h in fasted state for test and reference treatment	Area under the memantine plasma concentration-time curve	From zero to 72 hours post dose
Primary	Cmax of memantine in fed state for test and reference treatment	Maximum observed plasma concentration of memantine	From zero to 72 hours post dose
Primary	Cmax of memantine in fasted state for test and reference treatment	Maximum observed plasma concentration of memantine	From zero to 72 hours post dose
Secondary	tmax in fed state for test and reference treatment	Nominal time corresponding to the occurrence of Cmax	From zero to 72 hours post dose
Secondary	tmax in fasted state for test and reference treatment	Nominal time corresponding to the occurrence of Cmax	From zero to 72 hours post dose