Effects of Food on the Bioavailability and Pharmacokinetic Profile of Itasetron After a Single Oral Dose in Healthy Male Subjects

NCT ID: NCT02259985

Last Updated: 2014-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-03-31

Brief Summary

food interaction, pharmacokinetics, safety and tolerability

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Itasetron tablet fed

Group Type: EXPERIMENTAL

Itasetron tablet

Intervention Type: DRUG

high fat breakfast

Intervention Type: OTHER

Itasetron tablet fasted

Group Type: ACTIVE_COMPARATOR

Itasetron tablet

Intervention Type: DRUG

Itasetron infusion fasted

Group Type: ACTIVE_COMPARATOR

Itasetron infusion

Intervention Type: DRUG

Interventions

Itasetron tablet

Intervention Type: DRUG

Itasetron infusion

Intervention Type: DRUG

high fat breakfast

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

208.629

Identifier Type: -

Identifier Source: org_study_id