Status:
COMPLETED
Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
Lead Sponsor:
Swedish Orphan Biovitrum
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
Detailed Description
This is an open, randomized 2-way crossover study in 12 healthy volunteers. Subjects will receive single oral 20 mg doses of nitisinone administrated as one 20 mg capsule or as two 10 mg capsules of O...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers between 18-55 years of age, inclusive.
- BMI between 18,5-30,0 kg/m2, inclusive.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01857362
Start Date
May 1 2013
End Date
June 1 2013
Last Update
October 12 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pharmaceutical Research Associates Group B.V (PRA)
Zuidlaren, Netherlands, 9471 GP