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

NCT ID: NCT01857362

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-06-30

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 Orfadin. There will be a 3-week washout period between the doses.

There will be a screening visit within 3 weeks prior to the first dose. During each treatment period, subjects will be admitted to the clinic from the afternoon on the day before drug administration (i.e., on Day -1) and remain at the clinic until the 48-hour post-dose blood sample has been collected in the morning of Day 3. They will then return for ambulatory visit in the morning of Day 4 (72-hour sample). A follow-up visit will take place 7-14 days after the last dose.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nitisinone 2 x 10 mg

Two nitisinone 10 mg capsules by mouth as a single dose

Group Type: ACTIVE_COMPARATOR

Nitisinone 10 mg

Intervention Type: DRUG

Nitisinone 10 mg capsules

Nitisinone 1 x 20 mg capsule

One nitisinone 20 mg capsule by mouth as a single dose

Group Type: EXPERIMENTAL

Nitisinone 20 mg

Intervention Type: DRUG

Nitisinone 20 mg capsules

Interventions

Nitisinone 20 mg

Nitisinone 20 mg capsules

Intervention Type: DRUG

Nitisinone 10 mg

Nitisinone 10 mg capsules

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Orphan Biovitrum

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Brouwer, MD

Role: STUDY_DIRECTOR

Swedish Orphan Biovitrum

Locations

Pharmaceutical Research Associates Group B.V (PRA)

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

Sobi.NTBC-004

Identifier Type: -

Identifier Source: org_study_id