None listed
Conditions
Brief summary
The objective of this study is to evaluate the bioequivalence of the test (new) formulation of 10 mg asenapine sublingual tablet relative to that of the reference formulation (innovator brand of 10 mg asenapine sublingual tablet) following oral administration of a single dose of 10 mg in healthy male and female subjects under fasting conditions
Interventions
Single dose, crossover over study design whereby each participant receives the test formulation of asenapine sublingual (1 x 10 mg) on one occasion and the innovator formulation of asenapine sublingual (1 x 10 mg) on two occasions with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of asenapine.
Each dose (1 x 10 mg) will be placed under the subjects tongue. Subjects will be instructed not to chew or swallow the tablet but to allow it
Single dose, crossover over study design whereby each participant receives the test formulation of asenapine sublingual (1 x 10 mg) on one occasion and the innovator formulation of asenapine sublingual (1 x 10 mg) on two occasions with each dose seperated by a one week washout period. The intervention for this trial is the test formulation of asenapine. Each dose (1 x 10 mg) will be placed under the subjects tongue. Subjects will be instructed not to chew or swallow the tablet but to allow it to dissolve completely. Investigators will complete a mouth check at frequent intervals to ensure that the medication has been taken as directed and is fully dissolved. An allergy scratch test will be carried out the night prior to dosing. Subjects are required to consume 200ml of water one hour prior to dosing. At least 10 minutes prior to dosing subjects will be asked to void their bladder and the site of the scratch test will be checked to ensure that no drug sensitivity problems have been developed. 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 can 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 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. An allergy scratch test to determine sensitivity will be carried out during medical screening and prior to receving each asenapine dose.
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 Females Aged between 18 and 55 Non-smoker BMI between 19 and 30 Normal, healthy individuals as determined by medical history, physical examination, ECG, bood 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 Histroy of abnormal heartbeats or frequent palpitations or who have a family history of long QTc syndrome History of orthostatic hypotension, fainting or dizziness, epilepsy or seizures, diabetes or neuroleptic malignant syndrome History of depression, or other mental illness and/or have received treatment with antipsychotic medication Pregnant or breast-feeding Sensitivity to asenapine, any antipsychotic medicines, with excipients of asenapine History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug 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