Status:
COMPLETED
Pharmacokinetics in Adolescents
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
MALE
12-17 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to study pharmacokinetics in adolescents.
Detailed Description
An open, single centre, phase I study in male adolescents with asthma, aged 12 to 17 years, to assess pharmacokinetics of orally administered AZD1981 tablets 100 mg twice daily for 61/2 days.
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- A minimum of 6 months documented history of asthma
- Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to Visit 1 (pre-entry)
Exclusion
- Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate
- Any clinically relevant abnormal findings in phys.examination, clinical chemistry, haematology, urinalysis, vital signs, or ECG at baseline which, in the opinion of the investigator, may put the patient at risk because of his participation in the study
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01196689
Start Date
October 1 2010
End Date
February 1 2011
Last Update
March 7 2011
Active Locations (1)
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1
Research Site
Uppsala, Uppsala County, Sweden