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Study of New Tablet Formulations and Suspension Formulation Compared to Current (1B) Formulation of BILR 355 BS in Healthy Male Volunteer Subjects

NCT02259868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-08-31

No results posted yet for this study

Summary

1. To investigate the relative bioavailability (BA) of improved tablet formulation candidates to determine which formulation will be developed for use in late Phase II and Phase III clinical trials
2. To investigate the relative BA of the pediatric suspension, compared to the current 1B formulation
3. To investigate the bioequivalence (BE) of BILR 355 BS in two tablet strengths; three 25mg tablets vs. one 75 mg tablet, current 1B formulation

Conditions

  • Healthy

Interventions

DRUG

BILR 355 BS /1B, current low dose formulation

DRUG

BILR 355 BS /1B, current high dose formulation

DRUG

BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation

DRUG

BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation

DRUG

BILR 355 BS - Suspension low dose

DRUG

BILR 355 BS - Suspension high dose

DRUG

Ritonavir

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2005-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259868 on ClinicalTrials.gov