Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Nitisinone

Criteria

Inclusion Criteria:

• Healthy male volunteers

• Age: 18-55 years, inclusive

• BMI: 18,5-30,0 kg/m2, inclusive

Exclusion Criteria:

• heavy smokers

• Consumption of more than 4 cups of coffee per day.

• History of drug and/or alcohol abuse.

• Positive drug screen or alcohol breath test.

• Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.

• Enrollment in another concurrent clinical study

• Intake of an investigational medicinal product within three months prior to inclusion in this study.

• Donation of more than 50 mL of blood within 60 days prior to drug administration

• Donation of more than 1,5 liters of blood in the 10 months prior to first drug administration.