The Bioequivalence Of Two Different Lurasidone Formulations In Patients

Launched by SUMITOMO PHARMA AMERICA, INC. · Mar 5, 2010

Keywords

ClinConnect Summary

12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Body mass index (BMI) ≥ 19.5 and ≤ 37 kg/m2.
• • 3. No clinically relevant abnormal laboratory values.
• 4. No clinically significant findings in the 12-lead electrocardiogram (ECG):
• • 5. No clinically significant findings from a vital signs measurement.
• • 6. Able to understand and provide written consent prior to initiating any study procedure after being informed of the nature of the study.
• 7. Females who participate in this study:
• • are unable to have children (e.g. post-menopausal, tubal ligation, hysterectomy); OR
• • are willing to remain abstinent \[not engage in sexual intercourse\] from Day -5 until the final follow-up visit; OR
• • 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.
• • 8. 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:
• • 1. 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.
• • 2. Known history or presence of intolerance to psychiatric medications (e.g. atypical antipsychotic medications).
• • 3. History of alcohol or drug-dependence as per DSM-IV criteria during the 6-month period immediately prior to study entry.
• • 4. 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).
• • 5. 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.
• • 6. A history of epilepsy or risk of having seizures.
• 7. Positive test results within 30 days prior to the start of the study for:
• • 1. Human immunodeficiency virus (HIV).
• • 2. Hepatitis B surface antigen and Hepatitis C antibody.
• • 3. Urine drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
• • 4. Serum beta-HCG consistent with pregnancy (females only).
• • 8. Participated in another clinical trial or received an investigational product within 30 days prior to Screening.
• • 9. 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.
• • 10. Difficulty fasting or consuming the standard meals.
• • 11. 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.
• 12. Donation or loss of whole blood prior to drug administration, as follows:
• • 1. ≤ 499 mL within 30 days prior to dosing
• • 2. ≥ 500 mL within 56 days prior to dosing.
• • 13. Patient has a prolactin concentration ≥ 100 ng/mL at Screening.