Status:
COMPLETED
Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
21-50 years
Phase:
PHASE1
Brief Summary
food interaction, pharmacokinetics, safety and tolerability
Eligibility Criteria
Inclusion
- all participants in the study will range from 21 to 50 years of age and be within +- 20% of their normal weight (Broca-index)
- written informed consent in accordance with Good Clinical Practica and local legislation
Exclusion
- Subjects will be excluded from the study if the results of the medical examination or laboratory tests are judged by the investigator to differ significantly from normal clinical values
- Subjects with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Subjects with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
- Subjects with known history of orthostatic hypotension, fainting spells or blackouts
- Subjects with chronic or relevant acute infections
- Subjects with history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- Subjects who have taken a drug with a long half-life (\>= 24 hours) within one month before enrolment in the study
- Subjects who received any other drugs which might influence the results of the trial during the week previous the start of the study
- Subjects who have participated in another study with an investigational drug within the last 2 months preceding this study
- Subjects who are unable to refrain from smoking on study days
- Subjects who smoke more than 10 cigarettes (or 3 cigars or pipes) per day
- Subjects who drink more than 60 g of alcohol per day
- Subjects who are dependent on drugs
- Subjects who have donated blood (\>= 100 ml) within the last 4 weeks
- Subjects who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
Key Trial Info
Start Date :
March 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT02259985
Start Date
March 1 1998
Last Update
October 9 2014
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