Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
An Open, Single Centre, Single and Repeated Dose Study to Investigate the Pharmacokinetic Profile of Roflumilast and Roflumilast N-oxide After Administration of 500 μg Dose of Roflumilast in Healthy Chinese Subjects
Verified date | September 2016 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
The primary objective is to assess the pharmacokinetics (PK) of roflumilast and its metabolite roflumilast N-oxide after single and repeated oral administrations of roflumilast 500 μg in healthy Chinese subjects.
Status | Completed |
Enrollment | 32 |
Est. completion date | September 2011 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years and older |
Eligibility |
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 ß-HCG pregnancy test (female) - Pregnant or lactating females |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Nycomed Investigational Site | Beijing |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the pharmacokinetic profiles after single and repeated dose of roflumilast 500 µg administered to healthy Chinese subjects. | PK samples at pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h and 24h, 36h, 48h, 72h, 96h, 120h, 144h and 168h post dose after single dose and at the time points pre-dose, 0.25h, 0.5h, 0.75h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 16h and 24h after administration of a repeated dose | Period I: single dose, PK-Investigation over 8 days, Period II: repeated dose for 14 days, PK-Investigation on days 14 and 15 | No |
Secondary | The safety and tolerability of single and repeated dose roflumilast 500 µg will be evaluated in terms of adverse event, ECG, blood pressure, pulse rate, and clinical laboratory tests. | During screening, clinical part and final check | No |
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