The Bioequivalence Of Two Different Lurasidone Formulations In Patients
Study Details
Study Description
Brief Summary
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Detailed Description
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: Reference Formulation Dosed 12.5% drugload 3X40mg |
Drug: Lurasidone HCl
120mg dose. 3-way cross-over for 21 days
|
Other: Test Formulation 25% Drugload 1X120mg |
Drug: Lurasidone HCl
120mg dose. 3-way cross-over for 21 days
|
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorders as per DSM-IV or DSM-IV-TR criteria, which in the opinion of the investigator have been clinically stable for the past 6 months.
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Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m2.
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No clinically relevant abnormal laboratory values.
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No clinically significant findings in the 12-lead electrocardiogram (ECG):
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No clinically significant findings from a vital signs measurement.
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Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study.
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Females who participate in this study:
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are unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy); OR
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are willing to remain abstinent [not engage in sexual intercourse] from Day -5 until the final follow-up visit; OR
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are willing to use an effective method of double-barrier birth control (e.g. partner using condom and female using diaphragm, contraceptive sponge, spermicide, or intrauterine device [IUD]) from Day -5 until the final follow-up visit.
- Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until the final follow-up visit.
Exclusion Criteria:
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Significant disease(s) or clinically significant finding(s) in a physical examination determined by an Investigator to pose a health concern to the patient while on study.
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Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
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History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
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Significant orthostatic hypotension (i.e. a drop in systolic blood pressure of 30 mmHg or more and/or drop in diastolic blood pressure of 20 mmHg or more on standing).
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Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone.
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A history of epilepsy or risk of having seizures.
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Positive test results within 30 days prior to the start of the study for:
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Human immunodeficiency virus (HIV).
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Hepatitis B surface antigen and Hepatitis C antibody.
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Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
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Serum beta-HCG consistent with pregnancy (females only).
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Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
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Use of any inhibitor or inducer of CYP3A4 taken within 30 days prior to check-in, including but not limited to those listed in Appendix 19.3.
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Difficulty fasting or consuming the standard meals.
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Females taking oral or transdermal hormonal contraceptives within 14 days preceding period 1 dosing.
-OR- Females having used implanted or injected hormonal contraceptives within 6 months prior to period 1 dosing.
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Donation or loss of whole blood prior to drug administration, as follows:
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≤ 499 mL within 30 days prior to dosing
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≥ 500 mL within 56 days prior to dosing.
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Patient has a prolactin concentration ≥ 100 ng/mL at Screening.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | California Clinical Trials (CCT) | Glendale | California | United States | 91206 |
Sponsors and Collaborators
- Sunovion
Investigators
- Principal Investigator: Lev Gertsik, MD, California Clinical Trials (CCT)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D1050263