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Bioavailability of Four Oral Prototype Extended Release Formulations With BI 11634 in Healthy Male Volunteers

NCT02214953 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2014-08-13

No results posted yet for this study

Summary

To compare the oral bioavailability and rate of absorption of four prototype extended-release (ER) formulations with BI 11634 (single doses) to immediate-release (IR) tablets in healthy male volunteers.

Conditions

  • Healthy

Interventions

DRUG

BI 11634 ER formulation A

DRUG

BI 11634 ER formulation B

DRUG

BI 11634 ER formulation M

DRUG

BI 11634 ER formulation C

DRUG

BI 11634 IR tablet

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-12-31

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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 NCT02214953 on ClinicalTrials.gov