- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194218
Pharmacokinetic Properties of Nevirapine Extended Release Tablets When Administered Orally in Healthy Male Volunteers
July 17, 2014 updated by: Boehringer Ingelheim
An Open-label, Randomised, Single Dose, Parallel-group Phase I Study to Investigate the Pharmacokinetic Properties of 200 mg Nevirapine Extended Release Tablets When Administered Orally as 2x100 mg Tablets or as 4x50 mg Tablets in Healthy Male Volunteers
Study to determine the pharmacokinetic properties of 200 mg nevirapine (NVP) administered as 4 x 50 mg extended release (XR) tablets in a single dose and to establish the bioequivalence of this formulation compared to 200 mg NVP administered as 2 x 100 mg XR tablets in a single dose
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male 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; values within normal ranges or deviating from normal without clinical relevance as considered by the investigator
- Age ≥21 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 (GCP) 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
- Previous intake of Nevirapine
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 30 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nevirapine XR 4 doses
|
50 mg
|
Active Comparator: Nevirapine XR 2 doses
|
100 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Maximum measured concentration of the analyte in plasma (Cmax)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: up to 35 days
|
up to 35 days
|
Assessment of tolerability by investigator on a 4-point scale
Time Frame: within 8 days after last trial procedure
|
within 8 days after last trial procedure
|
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 (AUC0-tz)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Time from dosing to the maximum concentration of the analyte in plasma (tmax)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Terminal rate constant in plasma (λz)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Terminal half-life of the analyte in plasma (t1/2)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Mean residence time of the analyte in the body after po administration (MRTpo)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Apparent clearance of the analyte in the plasma after extravascular administration (CL/F)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Apparent volume of distribution during the terminal phase λz following an extravascular dose (Vz/F)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Absorption rate constant (ka)
Time Frame: up to 144 hours post-dose
|
up to 144 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
July 17, 2014
First Submitted That Met QC Criteria
July 17, 2014
First Posted (Estimate)
July 18, 2014
Study Record Updates
Last Update Posted (Estimate)
July 18, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1100.1531
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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