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Bioavailability of BIBR 1048 MS Single Doses With or Without Pantoprazole in Healthy Subjects

NCT02170805 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-06-23

No results posted yet for this study

Summary

The pharmacokinetics of 50 mg BIBR 1048 administered as two newly developed capsule formulation using melt extrusion technology was assessed in two separate, single dose, 3-way crossover, open design, randomised studies. The 3-way crossover treatments included administration of the tartaric acid solution of 50 mg BIBR 1048, the capsule formulation A or B and administration of the capsules with coadministration of pantoprazole.

Conditions

  • Healthy

Interventions

DRUG

BIBR 1048 MS capsule formulation A

BIBR 1048 MS, formulation A 50 mg

DRUG

BIBR 1048 MS capsule formulation B

BIBR 1048 MS, formulation B 50 mg

DRUG

BIBR 1048 MS powder plus solution

BIBR 1048 MS, powder plus solution 50 mg

DRUG

Pantoprazole

Pantoprazole 40 mg

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2001-06-30

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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 NCT02170805 on ClinicalTrials.gov