Bioequivalence of Orfadin 20 mg Compared to Orfadin 10 mg Capsules.
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.
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to evaluate the bioequivalence between Orfadin 20 mg and 10 mg capsules in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started May 2013
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 16, 2013
CompletedFirst Posted
Study publicly available on registry
May 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 27, 2014
CompletedOctober 12, 2021
September 1, 2021
1 month
May 16, 2013
June 9, 2014
September 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h).
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
The Maximum Serum Concentration (Cmax).
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
Study Arms (2)
Nitisinone 2 x 10 mg
ACTIVE COMPARATORTwo nitisinone 10 mg capsules by mouth as a single dose
Nitisinone 1 x 20 mg capsule
EXPERIMENTALOne nitisinone 20 mg capsule by mouth as a single dose
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female volunteers between 18-55 years of age, inclusive.
- BMI between 18,5-30,0 kg/m2, inclusive.
You may not qualify if:
- 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 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pharmaceutical Research Associates Group B.V (PRA)
Zuidlaren, 9471 GP, Netherlands
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr Erik Brouwer, Medical Director
- Organization
- Swedish Orphan Biovitrum
Study Officials
- STUDY DIRECTOR
Erik Brouwer, MD
Swedish Orphan Biovitrum
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2013
First Posted
May 20, 2013
Study Start
May 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 12, 2021
Results First Posted
October 27, 2014
Record last verified: 2021-09