Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.

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

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Treatments: Nitisinone

Criteria

Inclusion Criteria:

• Healthy male and female volunteers between 18-55 years of age, inclusive.

• BMI between 18,5-30,0 kg/m2, inclusive.

Exclusion Criteria:

• Subjects with current keratopathy, or other abnormalities found by slit-lamp examination.

• Subjects who are heavy smokers or consume more than 5 cups of coffee per day.

• Subjects with history of drug and/or alcohol abuse or a positive drug screen or alcohol breath test.

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

• Subjects who were enrolled in another concurrent clinical study or intake of an investigational medicinal product within three months prior to inclusion in this study.

• Subjects who donate more than 50 mL of blood within 60 days prior to drug administration or donate more than 1,5 liters of blood in the 10 months prior to first drug administration.

• Female subjects that are pregnant or breastfeeding.

• Female subjects of childbearing potential and all male subjects must be willing to use effective forms of contraception.