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

NCT01857362 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-10-12

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

Nitisinone 20 mg

Nitisinone 20 mg capsules

DRUG

Nitisinone 10 mg

Nitisinone 10 mg capsules

Sponsors & Collaborators

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Erik Brouwer, MD · Swedish Orphan Biovitrum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01857362 on ClinicalTrials.gov