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Clinical Trials/ACTRN12613000650796
ACTRN12613000650796
Completed
Phase 1

A open-label, balanced, randomised, single-dose, two-treatment, three-period, three-sequence, oral bioequivalence study of asenapine sublingual tablets in a three-way crossover, partial replicate, reference scaled, comparison against the innovator asenapine sublingual tablets conducted under fasting conditions in healthy male and female volunteers

Zenith Technology Corporation Limited0 sites36 target enrollmentJune 12, 2013
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ConditionsBioequivalence study on asenapine formulations.Schizophrenia in adultsOther - Research that is not of generic health relevance and not applicable to specific health categories listed aboveMental Health - Schizophrenia

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Bioequivalence study on asenapine formulations.
Sponsor
Zenith Technology Corporation Limited
Enrollment
36
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 12, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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