None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 3 x 0.5 mg against the reference formulation (innovator brand of 3 x 0.5 mg fingolimod capsule) following oral administration of a single dose of 3 x 0.5 mg in healthy male and female subjects under fed 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 (3 x 0.5 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 ens
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 (3 x 0.5 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. 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 9.5 hours prior to breakfast and dosing and are required to fast for approximately 4 hours after receiving each dose. Participants will be provided with a standardised high fat content breakfast which they must start eating 30 minutes prior to dosing. 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. Standard meals will be consumed at the Clinical Site with no additional food intake allowed. Alcohol breath testing, dipstick drugs of abuse testing and an ECG 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 healthy of participants along with HIV, Hepatitis and drugs of abuse testing.
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 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 Who have received an investigational compound or drug known to induce or inhibit liver enzymes within 60 days of the start of the study History or family history of depression or other mental illness, epilepsy or seizures Who have a history of bleeding disorders or blood clotting problems 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 Who are lactose intolerant 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) 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 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