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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: NVP ER 300 mg (KCR 20%) Medium Release; Drug: NVP ER 300 mg (KCR 25%) Medium Release; Drug: Nevirapine immediate release (IR) 200 mg; Drug: NVP ER 400 mg (KCR 40%) Slow Release; Drug: NVP ER 300 mg (KCR 30%) Slow Release; Drug: NVP ER 300 mg (KCR 40%) Slow Release; Drug: NVP ER 300 mg (ECR 20%) Fast Release; Drug: NVP ER 400 mg (ECR 20%) Fast Release; Drug: NVP ER 400 mg (KCR 30%) Slow Release; Drug: NVP ER 400 mg (KCR 25%) Medium Release; Drug: NVP ER 400 mg (KCR 20%) Medium Release

Study type: Interventional

Funder types: Industry

Identifiers

NCT02192463

1100.1485

Details and patient eligibility

About

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

Enrollment: 204 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 12 patient groups

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

Experimental group

Treatment:

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

NVP ER 300 mg (KCR 25%) Medium Release

Experimental group

Treatment:

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

NVP ER 300 mg (KCR 30%) Slow Release

Experimental group

Treatment:

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

NVP ER 400 mg (KCR 25%) Medium Release

Experimental group

Treatment:

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

NVP ER 300 mg (KCR 40%) Slow Release

Experimental group

Treatment:

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

NVP ER 300 mg (ECR 20%) Fast Release

Experimental group

Treatment:

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

NVP ER 400 mg (KCR 20%) Medium Release

Experimental group

Treatment:

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

NVP ER 400 mg (KCR 30%) Slow Release

Experimental group

Treatment:

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

NVP ER 400 mg (KCR 40%) Slow Release

Experimental group

Treatment:

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

NVP ER 400 mg (ECR 20%) Fast Release

Experimental group

Treatment:

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

Nevirapine IR 1 tablet

Active Comparator group

Treatment:

Drug: Nevirapine immediate release (IR) 200 mg

Nevirapine IR 2 tablets

Active Comparator group

Treatment:

Drug: Nevirapine immediate release (IR) 200 mg