None listed
Conditions
Brief summary
The objective of this pilot study is to evaluate the bioequivalence of the test formulation relative to the that of a reference formulation, following oral administration of a combination single dose of 240 mg dimethyl fumarate capsule to healthy male and female subjects under fasting conditions.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of 240 mg dimethyl fumarate capsule on one occasion and the innovator formulation of 240 mg dimethyl fumarate capsule on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test capsule formulation.
No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the dose).
Participants are required not to eat
Single dose, crossover study design whereby each participant receives the test formulation of 240 mg dimethyl fumarate capsule on one occasion and the innovator formulation of 240 mg dimethyl fumarate capsule on one occasion with each dose separated by a one week washout period. The intervention for this trial is the test capsule formulation. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for water consumed with the dose). Participants are required not to eat for 10 hours before receiving each dose and to fast for approximately 4 hours after receiving each dose. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing will be performed upon each participant reporting to the Clinical Site 10 hours prior to dosing. Pre and post study laboratory tests will be completed to assess the health of participants along with HIV, Hepatitis and drugs of abuse testing. Each dose ( 1 x 204 mg) will be taken orally with 240 ml of water at ambient temperature. Medication must be swallowed whole and a mouth check will be conducted to ensure the medication has been taken as directed.
Sponsors
Zenith Technology Corporation Limited
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males and non-pregnant female volunteers. Aged between 18 and 55 Non-smoker BMI between 18.5 and 32 Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent
Exclusion criteria
Concomitant drug therapy of any kind Any clinically significant medical conditions Sensitive to the study drug History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug Females who are pregnant and/or breastfeeding Smoker (anyone who has smoked in the last 6 months) History of alcohol or drug abuse or dependency Participation in a drug study within 60 days of the start of the study or donated blood within the 60 days preceding the study Volunteers for whom the Clinical Investigator believer, for any reason, that participation would not be an acceptable risk
Outcome results
None listed