Pharmacokinetic Study of Single and Repeated Dose of Roflumilast 500 µg , in Healthy Chinese Subjects
NCT ID: NCT01354782
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2011-05-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Roflumilast
(This is a pharmacokinetic study)
Roflumilast
Period I: single dose of roflumilast 500 μg orally in the morning.
Period II: repeated dose of roflumilast 500 μg orally in the morning for 14 days.
Interventions
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Roflumilast
Period I: single dose of roflumilast 500 μg orally in the morning.
Period II: repeated dose of roflumilast 500 μg orally in the morning for 14 days.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca AstraZeneca
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Nycomed Investigational Site
Beijing, , China
Countries
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Related Links
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RO-2455-101-EC-RDS-2012-04-26.pdf
Other Identifiers
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RO-2455-101-EC
Identifier Type: -
Identifier Source: org_study_id