Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Healthy male and female (24 male and 8 female) subjects of Chinese ethnic origin, age 40 years and older.
Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure, pulse rate, ECG assessment, and clinical laboratory results.
Body weight according to a Body Mass Index (BMI) between 19 and 28 kg/\[m²\], (both inclusive) and a body weight ≥ 50 kg.
Females with childbearing potential who are using medically acceptable and reliable method of contraception for the entire study duration, such as tubal ligation, hysterectomy, intrauterine device without hormones or post-menopausal females, the latter is defined as females who have had no menstrual period for at least 2 years.
You may not be if
History or current evidence of clinically relevant allergies or idiosyncrasy to drugs or food
History of allergic reactions to roflumilast or any inactive ingredients of the trial medication
History or current evidence of any clinically relevant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease (within the last 2 years)
History of malignancy within the past 5 years
Electrocardiogram (ECG) abnormalities of clinical relevance (e.g. QTc according to Bazett's formula: QTc \> 450 msec (male), QTc \> 470 msec (female), PQ ≥ 220 msec)
Blood pressure ≥ 140 mm HG systolic or ≥ 90 mm HG diastolic
Elevated transaminases \> 2 x upper Limit of normal range and or increased of the total bilirubin \> 1.5 upper Limit of normal range
Clinically relevant abnormalities in clinical chemical, hematological or any other laboratory variables
Chronic or clinically relevant acute infections
Proneness to orthostatic dysregulation, faintings, or blackouts
Positive results in any of the virology tests of acute or chronic infectious HIV and hepatitis A, B, and C virus infections
