Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects who have successfully completed a ziprasidone clinical study
Patients not hospitalised in an acute psychiatric service
Written, informed consent to participation.
Female patients of at risk of pregnancy must avoid to remain pregnant; an adequate method of contraception (intrauterine device, implanted contraceptive, oral contraceptive or condom) must be initiated or continued
You may not be if
Psychiatric:
Subjects at immediate risk of committing harm to self or others
Subjects requiring concurrent treatment with non-study antipsychotic agents
Subjects requiring treatment with antidepressants or mood stabilizers
General:
Subjects with a history of clinically significant and/or currently relevant hematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer (excluding melanoma). Controlled Type II diabetes (glucose \< 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study
Acute or chronic heart disease
Clinically significant ECG abnormalities
Subjects with QTc \>= 500 msec (subjects with QTc \>= 450 msec and \< 500 msec should be discussed with the cardiologist who is responsible for all of the centers involved)
Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments)
Subjects with serum K+ or Mg++ outside the normal range
Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator
Known serological evidence of HIV, or acute or chronic hepatitis (with transaminase levels higher than three times upper limit)
Pregnant or lactating women
Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends
Subjects unable or unlikely to follow the study protocol
Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds
