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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01857362
Recruitment Status : Completed
First Posted : May 20, 2013
Results First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Information provided by (Responsible Party):
Swedish Orphan Biovitrum

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Nitisinone 20 mg Drug: Nitisinone 10 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Bioequivalence of Orfadin Capsules 20 mg Compared to Orfadin Capsules 10 mg. An Open-label, Randomized, Cross-over, Single-dose Study in Healthy Volunteers.
Study Start Date : May 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Nitisinone

Arm Intervention/treatment
Active Comparator: Nitisinone 2 x 10 mg
Two nitisinone 10 mg capsules by mouth as a single dose
Drug: Nitisinone 10 mg
Nitisinone 10 mg capsules

Experimental: Nitisinone 1 x 20 mg capsule
One nitisinone 20 mg capsule by mouth as a single dose
Drug: Nitisinone 20 mg
Nitisinone 20 mg capsules

Primary Outcome Measures :
  1. The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h). [ Time Frame: Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ]
  2. The Maximum Serum Concentration (Cmax). [ Time Frame: Day 1 predose and at 15, 30, 45 minutes and 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01857362

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Pharmaceutical Research Associates Group B.V (PRA)
Zuidlaren, Netherlands, 9471 GP
Sponsors and Collaborators
Swedish Orphan Biovitrum
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Study Director: Erik Brouwer, MD Swedish Orphan Biovitrum
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Responsible Party: Swedish Orphan Biovitrum Identifier: NCT01857362    
Other Study ID Numbers: Sobi.NTBC-004
First Posted: May 20, 2013    Key Record Dates
Results First Posted: October 27, 2014
Last Update Posted: October 27, 2014
Last Verified: October 2014
Keywords provided by Swedish Orphan Biovitrum:
Additional relevant MeSH terms:
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Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action