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Relative Bioavailability of Different Formulations of BI 671800 in Healthy Male and Female Volunteers

NCT02221388 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-08-20

No results posted yet for this study

Summary

To compare the oral bioavailability and rate of absorption of two different formulations of BI 671800 HEA (choline salt) tablets 200 mg, one with enteric coating (EC) and one without EC, versus 2 x 100 mg BI 671800 ED (ethylenediamine salt) capsules. Both BI 671800 HEA formulations were further investigated concerning food effect and one of the two BI 671800 HEA formulations identified by interim pharmacokinetic analysis was further investigated concerning dose proportionality with 50 mg.

Conditions

  • Healthy

Interventions

DRUG

BI 671800 HEA, 200 mg tablets

DRUG

BI 671800 HEA EC, 200 mg tablets

DRUG

BI 671800 HEA, 50 mg tablets

DRUG

BI 671800 ED, 100 mg capsules

OTHER

Standard meal

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-07-31

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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 NCT02221388 on ClinicalTrials.gov