Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers
NCT ID: NCT02253953
Last Updated: 2014-10-01
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
62 participants
INTERVENTIONAL
2002-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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D1
BILR 355 BS, D1
Ritonavir
D2
BILR 355 BS, D2
Ritonavir
D3
BILR 355 BS, D3
Ritonavir
D4
BILR 355 BS, D4
Ritonavir
D5
BILR 355 BS, D5
Ritonavir
D6
BILR 355 BS, D6
Ritonavir
D7
BILR 355 BS, D7
Ritonavir
D8
BILR 355 BS, D8
Ritonavir
D10
BILR 355 BS, D10
high-fat breakfast
Ritonavir
Placebo
for D3 - D10
Placebo
Ritonavir
Interventions
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BILR 355 BS, D1
BILR 355 BS, D2
BILR 355 BS, D3
BILR 355 BS, D4
BILR 355 BS, D5
BILR 355 BS, D6
BILR 355 BS, D7
BILR 355 BS, D8
BILR 355 BS, D10
Placebo
high-fat breakfast
Ritonavir
Eligibility Criteria
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Inclusion Criteria
* Age range from 21 to 50 years
* Body mass index (BMI) be within 18.5 to 29.9 kg/m2
* In accordance with Good Clinical Practice and the local legislation all volunteers will have given their written informed consent prior to admission to the study
Exclusion Criteria
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
* Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug (≤ two months prior to administration or during the trial)
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation (≥ 100 mL within four weeks prior to administration or during the trial)
* Any laboratory value outside the clinically accepted reference range
* Excessive physical activities within the last week before the trial or during the trial
* Erythema, exanthema and comparable skin alterations
21 Years
50 Years
MALE
Yes
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Other Identifiers
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1188.4
Identifier Type: -
Identifier Source: org_study_id
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