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Relative Bioavailability of Sorafenib Tablet for Oral Suspension

NCT02538393 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-06-01

No results posted yet for this study

Summary

The primary objective of the study is to

• Investigate the relative bioavailability of sorafenib as 400 mg (4 x 100 mg) tablet for oral suspension formulation in comparison to 400 mg (2 x 200 mg) marketed tablet formulation.

The secondary objectives of this study are to

* Evaluate the dose proportionality in sorafenib pharmacokinetics for sorafenib tablet for oral suspension formulation after administration of 200 mg (2 x 100 mg) and 400 mg (4 x 100 mg) dose of sorafenib in fasted state
* Evaluate the effect of food on the pharmacokinetics of the tablet for oral suspension formulation after administration of a single dose of 400 mg sorafenib (4 x 100mg)
* Evaluate the taste and palatability of sorafenib (both formulations)
* Assess the safety and tolerability of sorafenib tablet for oral suspension in healthy male subjects

Conditions

  • Biological Availability

Interventions

DRUG

Sorafenib (BAY43-9006) Film-coated tablet

Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 \* 200 mg) in fasting state in Treatment A

DRUG

Sorafenib (BAY43-9006) Oral suspension

Treatment C: Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 \* 100 mg) in fasting state in the second intervention period; Treatment B: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) in fasting state in the third intervention period; Treatment D: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 \* 100 mg) after a high-fat, high-calorie breakfast (fed state) in the fourth intervention period.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-11-20
Primary Completion
2016-03-15
Completion
2016-06-15
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Companies

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 NCT02538393 on ClinicalTrials.gov