None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of fingolimod against the reference formulation (innovator brand of fingolimod) following oral administration of a single dose of 1.5 mg in healthy male and female subjects under fasting conditions.
Interventions
Single dose, crossover study design whereby each participant receives the test formulation of fingolimod (3 x 0.5 mg) on one occasion and the innovator formulation of fingolimod (3 x 0.5 mg) on one occasion with each dose seperated by a six week washout period. The intervention for this trial is the test formulation of fingolimod.
Each dose 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 medic
Single dose, crossover study design whereby each participant receives the test formulation of fingolimod (3 x 0.5 mg) on one occasion and the innovator formulation of fingolimod (3 x 0.5 mg) on one occasion with each dose seperated by a six week washout period. The intervention for this trial is the test formulation of fingolimod. Each dose 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. No water is allowed for 1 hour prior to dosing until 1 hour after dosing (except for the 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. Bathroom visits will be supervised to ensure no unauthorised water or food intake and for personal safety. Participants will be confined at the Clinical Site for 10 hours prior to dosing to ensure compliance and will be monitored and for 24 hours after dosing. Screening (pre study) and post study laboratory tests will be completed to assess the health of participants.
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 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy males and non-pregnant females Aged between 18 and 45 Non-smoker BMI between 18 and 25 inclusive Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure and laboratory tests Able to provide written informed consent
Exclusion criteria
Any history of recent recurrent attacks of bronchitis, asthma, migraine headaches Concomitant drug therapy of any kind excluding prescribed hormonal contraceptives Sensitivity to fingolimod any other similar class medicines, excipients of fingolimod History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug Who have any eye problems or conditions especially inflammation of the eye Who have had a clinical illness within 4 weeks prior to the start of the study Who have received any vaccinations within 1 month prior to dosing Females who are breastfeeding or are planning to start a family within 60 days of dosing Who are planning on having any surgical or dental procedures within 4 weeks of the study completion Smoker (anyone who has smoked in the last 6 months) Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study. Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk.
Outcome results
None listed