Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects

Main Inclusion Criteria: * 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. Main Exclusion Criteria: * 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 * Positive drug screen * Abuse of alcohol or drugs * Positive β-HCG pregnancy test (female) * Pregnant or lactating females