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The Bioequivalence Of Two Different Lurasidone Formulations In Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01082250
Recruitment Status : Completed
First Posted : March 8, 2010
Last Update Posted : September 8, 2011
Sponsor:
Information provided by (Responsible Party):
Sunovion

Brief Summary:
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Lurasidone HCl Phase 1

Detailed Description:
12.5% Drugload 3X40mg vs. 25% Drugload 1X120mg

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: AN OPEN-LABEL, RANDOMIZED, THREE-PERIOD, TWO-SEQUENCE CROSSOVER, REPEATED-DOSE, REPLICATE DESIGN STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO DIFFERENT LURASIDONE FORMULATIONS IN PATIENTS WITH SCHIZOPHRENIA, SCHIZOAFFECTIVE, OR SCHIZOPHRENIFORM DISORDER
Study Start Date : July 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Reference Formulation
Dosed 12.5% drugload 3X40mg
Drug: Lurasidone HCl
120mg dose. 3-way cross-over for 21 days

Test Formulation
25% Drugload 1X120mg
Drug: Lurasidone HCl
120mg dose. 3-way cross-over for 21 days





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082250


Locations
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United States, California
California Clinical Trials (CCT)
Glendale, California, United States, 91206
Sponsors and Collaborators
Sunovion
Investigators
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Principal Investigator: Lev Gertsik, MD California Clinical Trials (CCT)
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Responsible Party: Sunovion
ClinicalTrials.gov Identifier: NCT01082250    
Other Study ID Numbers: D1050263
First Posted: March 8, 2010    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Keywords provided by Sunovion:
Bioequivalence
Male/Female Patient
Reference/Test Formulation
Schizophrenia Patients
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Lurasidone Hydrochloride
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic alpha-2 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents