Study record managers: refer to the Data Element Definitions if submitting registration or results information. Washout period between doses was 7 days. 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. The normal status of subjects will be confirmed by the following procedures:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U.
Federal Government. Read our disclaimer for details. Last Update Posted : October 19, Study Description. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Inclusion Criteria: Males or non-pregnant, non-lactating females, 18 years of age or older. Female subjects must be postmenopausal for at least one year, or surgically sterile, or practicing adequate non-hormonal contraception for at least 3 months prior to and for the duration of study participation.
All female subjects will undergo a pregnancy test at screening and at check-in to the clinical study site for every dosing period. The results of the test must be negative for continued participation. Qualifying subjects must be in good health and physical condition as determined by a screening medical history obtained within 30 days prior to study start. Subjects should not present with a history of significant past illness expected to affect the investigation.
The normal status of subjects will be confirmed by the following procedures: Laboratory tests chemistry, hematology, urinalysis Human immunodeficiency virus HIV , hepatitis, alcohol, and "drugs of abuse" testing will be done for screening purposes only. Results of the HIV, hepatitis, and "drugs of abuse" tests must be negative or non-reactive for subjects to qualify for the study.
Electrocardiogram: A lead electrocardiogram ECG will be obtained for all subjects. This ECG must be interpreted by appropriately trained and experienced medical personnel.
A subject with an ECG that is not within normal range does not qualify, unless specifically accepted with comment by the investigator. Subjects must be able to provide written consent and agree to abide by the study requirements including consuming the entire standardized breakfast.
Prostatic hypertrophy. Urethral stricture. Severe hepatic or renal impairment. Pregnancy Cat. Nursing mothers: not recommended. Increased risk of respiratory depression, sedation with benzodiazepines or other CNS depressants eg, opioids, antihistamines, antipsychotics, anxiolytics, alcohol ; avoid. Paralytic ileus may occur with anticholinergics. Nausea, vomiting, sedation, drowsiness, impairment of mental and physical performance, dysphoria, rash, pruritus; respiratory depression.
Adult Dosage: Use accurate measuring device. Children Dosage: Use accurate measuring device. Adverse Reactions: Nausea, vomiting, sedation, drowsiness, impairment of mental and physical performance, dysphoria, rash, pruritus; respiratory depression.
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