NCT02367027

Relative Bioavailability Study in Healthy Subjects Comparing 2 Dry Powder Oral Suspensions of Rivaroxaban Under Fasting and 20 mg of an Oral Suspension of Rivaroxaban Under Fed Conditions to 10 mg of an Immediate Release Tablet Under Fasting Conditions

Single-dose, Open-label, Randomized, 4-way Crossover Study to Compare a Dry Powder Oral Suspension (10 mg and 20 mg Dose of Rivaroxaban) With an Oral Suspension (10 mg of Rivaroxaban) and 10 mg of an Immediate Release Tablet Under Fasting Conditions (10 mg Doses) and Under Fed Conditions (20 mg Dose) in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Rivaroxaban is a substance developed for use in the treatment of blood coagulation disorders.Thrombosis (blood clots) can occur as a result of excessive coagulation activity in the blood vessels. Excessive coagulation activity can occur in children as well, and rivaroxaban is therefore being developed for the treatment of thromboembolic events in children and adolescents. As small children are often unable to swallow tablets, an oral suspension (mixture of a liquid containing finely distributed solids) has been developed which allows dosing according to body weight.The objective of this trial is to compare the bioavailability (proportion of a substance that remains available unchanged in the blood circulation) of a new oral suspension of rivaroxaban with a previously used oral suspension and with a rivaroxaban tablet approved for treatment. In order to evaluate the potential influence of food, the new oral suspension containing 20 mg rivaroxaban will be taken after consuming food. In addition, the pharmacokinetics (concentrations of the drug and breakdown products (metabolites) in blood), safety and tolerability will be assessed.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Single dose of 10 mg oral suspension (dry powder) in fasted conditions.
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Single dose of 20 mg oral suspension (dry powder) in fed conditions.
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Single dose of 10 mg oral suspension in fasted conditions.
DRUG	Rivaroxaban (Xarelto, BAY59-7939)	Single dose of 10 mg tablet in fasted conditions.

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2015-02-20
• Last updated: 2015-06-10

Locations

1 site across 1 country: Germany