Pharmacokinetic Properties of Nevirapine Extended Release Tablets When Administered Orally in Healthy Male Volunteers

NCT02194218 | Completed Phase 1

• 1 other identifier: 1100.1531
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 144 hours post-dose

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 144 hours post-dose

Secondary Outcomes (10)

• 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)

  up to 144 hours post-dose

• Time from dosing to the maximum concentration of the analyte in plasma (tmax)

  up to 144 hours post-dose

• Terminal rate constant in plasma (λz)

  up to 144 hours post-dose

• Terminal half-life of the analyte in plasma (t1/2)

  up to 144 hours post-dose

• Mean residence time of the analyte in the body after po administration (MRTpo)

  up to 144 hours post-dose

Study Arms (2)

Nevirapine XR 4 doses

EXPERIMENTAL

Drug: Nevirapine, low dose

Nevirapine XR 2 doses

ACTIVE COMPARATOR

Drug: Nevirapine, high dose

Interventions

Nevirapine, low dose DRUG

50 mg

Nevirapine XR 4 doses

Nevirapine, high dose DRUG

100 mg

Nevirapine XR 2 doses

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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)

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2014
• First Posted: July 18, 2014
• Study Start: September 1, 2009
• Primary Completion: November 1, 2009
• Last Updated: July 18, 2014

Record last verified: 2014-07