Relative Bioavailability of Different Oral Viramune Extended Release Formulations Compared to Viramune® Oral Suspension in Healthy Male Volunteers

NCT02192463 | Completed Phase 1

• 1 other identifier: 1100.1485
• Study Type: interventional
• Target: 204
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to determine the relative bioavailability of different oral Viramune Extended Release (ER) formulations compared to Viramune® Immediate Release (IR) tablet

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (12)

Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release

EXPERIMENTAL

Drug: NVP ER 300 mg (KCR 20%) Medium Release

NVP ER 300 mg (KCR 25%) Medium Release

EXPERIMENTAL

Drug: NVP ER 300 mg (KCR 25%) Medium Release

NVP ER 300 mg (KCR 30%) Slow Release

EXPERIMENTAL

Drug: NVP ER 300 mg (KCR 30%) Slow Release

NVP ER 400 mg (KCR 25%) Medium Release

EXPERIMENTAL

Drug: NVP ER 400 mg (KCR 25%) Medium Release

NVP ER 300 mg (KCR 40%) Slow Release

EXPERIMENTAL

Drug: NVP ER 300 mg (KCR 40%) Slow Release

NVP ER 300 mg (ECR 20%) Fast Release

EXPERIMENTAL

Drug: NVP ER 300 mg (ECR 20%) Fast Release

NVP ER 400 mg (KCR 20%) Medium Release

EXPERIMENTAL

Drug: NVP ER 400 mg (KCR 20%) Medium Release

NVP ER 400 mg (KCR 30%) Slow Release

EXPERIMENTAL

Drug: NVP ER 400 mg (KCR 30%) Slow Release

NVP ER 400 mg (KCR 40%) Slow Release

EXPERIMENTAL

Drug: NVP ER 400 mg (KCR 40%) Slow Release

NVP ER 400 mg (ECR 20%) Fast Release

EXPERIMENTAL

Drug: NVP ER 400 mg (ECR 20%) Fast Release

Nevirapine IR 1 tablet

ACTIVE COMPARATOR

Drug: Nevirapine immediate release (IR) 200 mg

Nevirapine IR 2 tablets

ACTIVE COMPARATOR

Drug: Nevirapine immediate release (IR) 200 mg

Interventions

NVP ER 300 mg (KCR 20%) Medium Release DRUG

Nevirapine (NVP) ER 300 mg (KCR 20%) Medium Release

NVP ER 300 mg (KCR 25%) Medium Release DRUG

NVP ER 300 mg (KCR 25%) Medium Release

NVP ER 300 mg (KCR 30%) Slow Release DRUG

NVP ER 300 mg (KCR 30%) Slow Release

NVP ER 400 mg (KCR 25%) Medium Release DRUG

NVP ER 400 mg (KCR 25%) Medium Release

NVP ER 300 mg (KCR 40%) Slow Release DRUG

NVP ER 300 mg (KCR 40%) Slow Release

NVP ER 300 mg (ECR 20%) Fast Release DRUG

NVP ER 300 mg (ECR 20%) Fast Release

NVP ER 400 mg (KCR 20%) Medium Release DRUG

NVP ER 400 mg (KCR 20%) Medium Release

NVP ER 400 mg (KCR 30%) Slow Release DRUG

NVP ER 400 mg (KCR 30%) Slow Release

NVP ER 400 mg (KCR 40%) Slow Release DRUG

NVP ER 400 mg (KCR 40%) Slow Release

NVP ER 400 mg (ECR 20%) Fast Release DRUG

NVP ER 400 mg (ECR 20%) Fast Release

Nevirapine immediate release (IR) 200 mg DRUG

Nevirapine IR 1 tablet; Nevirapine IR 2 tablets

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Nevirapine

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2014
• First Posted: July 16, 2014
• Study Start: April 1, 2006
• Primary Completion: August 1, 2006
• Last Updated: July 16, 2014

Record last verified: 2014-07