Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Registration Number
- NCT02192463
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 204
Inclusion Criteria
- Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory
- Age ≥18 and Age ≤50 years
- Body Mass Index (BMI) ≥18.5 and BMI ≤29.9 kg/m2
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation
Exclusion Criteria
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders of clinical relevance
- Surgery of the gastrointestinal tract (except appendectomy and herniotomy)
- 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
- Excessive physical activities (within one week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of trial site
- A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a corrected QT interval (QTc) >450 ms)
- A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
- History of disease which affects the present situation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NVP ER 400 mg (KCR 25%) Medium Release NVP ER 400 mg (KCR 25%) Medium Release - NVP ER 300 mg (KCR 40%) Slow Release NVP ER 300 mg (KCR 40%) Slow Release - NVP ER 300 mg (ECR 20%) Fast Release NVP ER 300 mg (ECR 20%) Fast Release - NVP ER 400 mg (KCR 20%) Medium Release NVP ER 400 mg (KCR 20%) Medium Release - NVP ER 400 mg (KCR 30%) Slow Release NVP ER 400 mg (KCR 30%) Slow Release - Nevirapine IR 1 tablet Nevirapine immediate release (IR) 200 mg - Nevirapine IR 2 tablets Nevirapine immediate release (IR) 200 mg - NVP ER 300 mg (KCR 25%) Medium Release NVP ER 300 mg (KCR 25%) Medium Release - NVP ER 400 mg (ECR 20%) Fast Release NVP ER 400 mg (ECR 20%) Fast Release - Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release NVP ER 300 mg (KCR 20%) Medium Release - NVP ER 300 mg (KCR 30%) Slow Release NVP ER 300 mg (KCR 30%) Slow Release - NVP ER 400 mg (KCR 40%) Slow Release NVP ER 400 mg (KCR 40%) Slow Release -
- Primary Outcome Measures
Name Time Method AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) up to 144 hours post-dose Cmax (maximum measured concentration of the analyte in plasma) up to 144 hours post-dose C24 (measured concentration of the analyte in plasma at 24 hours post-dose) 24 hours post-dose
- Secondary Outcome Measures
Name Time Method Cmax/C24 ratio up to 144 hours post-dose AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point) up to 144 hours post-dose λz (terminal rate constant in plasma) up to 144 hours post-dose t1/2 (terminal half-life of the analyte in plasma) up to 144 hours post-dose MRTpo (mean residence time of the analyte in the body after po administration) CL/F (apparent clearance of the analyte in the plasma after extravascular administration) up to 144 hours post-dose Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose) up to 144 hours post-dose ka (absorption rate constant) up to 144 hours post-dose Number of patients with adverse events up to 36 days Assessment of tolerability by investigator on a 4-point scale within 8 days after last trial procedure tmax (time from dosing to the maximum concentration of the analyte in plasma) up to 144 hours post-dose