Comparative assessment of the absorption of a generic formulation of asenapine sublingual tablet against the innovator asenapine sublingual tablet conducted under fasting conditions in healthy male and female volunteers

Phase 1

Completed

• Conditions: Bioequivalence study on asenapine formulations.; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above; Schizophrenia in adults; Mental Health - Schizophrenia

• Registration Number: ACTRN12613000650796
• Lead Sponsor: Zenith Technology Corporation Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the bioavailability of asenapine (as summarised by Cmax and AUC) for the two formulations. If the within-subject variability is 30% or more then the referenced-scaled average bioequivalence approach will be used. All plasma samples will be assayed for asenapine using a fully validated LC/MS/MS method. Validation will be conducted to comply with EU and FDA guidelines. [0, 0.16, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 56 and 72 hours]

Secondary Outcome Measures

Name	Time	Method
Time to maximum peak concentration (Tmax) and the elimination half life (t1/2). Tmax will be the time where the maximum concentration occurred in the sample points. T1/2 = 0.693/Kel where kel is the terminal elimination rate constant. [0, 0.16, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 18, 24, 32, 48, 56 and 72 hours]