Status:
COMPLETED
Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief Summary
1. To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials 2....
Eligibility Criteria
Inclusion
- Healthy HIV negative adult male volunteers
- Age ≥18 and ≤ 60 years
- BMI ≥18.5 and BMI ≤29.9 kg/m2
- Ability to give signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local regulations
Exclusion
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
- History of relevant 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 prior to study drug administration and during the trial
- Use of drugs within 10 days prior to administration or during the trial which might reasonably influence the results of the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Current smoker
- Alcohol abuse (more than 60 g/day)
- Drug abuse (positive urine test for illicit prescription or non-prescription drugs or drugs of abuse).
- Blood donation (more than 100 mL within four weeks prior to study drug administration or during the trial)
- Excessive physical activities (within one week prior to study drug administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance at screening, according to the judgment of the investigator
- Inability to comply with dietary regimen required by the protocol
- Infected with hepatitis B or hepatitis C viruses (defined as either being hepatitis B surface antigen, or hepatitis C antibody positive
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT02259868
Start Date
June 1 2005
Last Update
August 31 2018
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