Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Participants must be 18 to 55 years of age, inclusive, at the time of signing the Informed Consent Document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, full physical examination, vital signs, 12-lead electrocardiogram (ECG), and/or clinical laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations , and other study procedures.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb).
Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
You may not be if
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Any condition possibly affecting drug absorption (eg, gastrectomy).
History of Human Immunodeficiency Virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed.
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
A positive urine drug test.
Screening supine blood pressure (BP) ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest.
Baseline standard 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary:
aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≥1.5 × upper limit of normal (ULN);
Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN.
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day. For chewing tobacco, one chew is equivalent to approximately 2 to 3 cigarettes, so participants would be limited to 2 or less chews per day.
History of sensitivity to prazosin hydrochloride or any of the components in the formulation of the study products.
