Status:
COMPLETED
Single Rising Dose (SRD), Multiple Rising Dose (MRD) Study of BI 671800 in Healthy Asian Volunteers
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Asthma
Rhinitis, Allergic, Perennial
Eligibility:
MALE
20-50 years
Phase:
PHASE1
Brief Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 671800 HEA in healthy Chinese male volunteers following single oral administration, and healthy Japanese ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Healthy
- Chinese ethnicity for single rising dose (SRD) part, Japanese Ethnicity for multiple rising dose (MRD) part.
- Age \>= 20 and age =\< 50
- Body Mass Index (BMI) \>=18.5 and BMI =\< 25 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation
- Exclusion criteria:
- Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
- Any evidence of a clinically relevant concomitant disease
- Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT01216384
Start Date
October 1 2010
Last Update
November 19 2013
Active Locations (1)
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1
1268.15.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea