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

Information source: Swedish Orphan Biovitrum
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Nitisinone 20 mg (Drug); Nitisinone 10 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Swedish Orphan Biovitrum

Official(s) and/or principal investigator(s):
Erik Brouwer, MD, Study Director, Affiliation: Swedish Orphan Biovitrum

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Area Under the Serum Concentration vs. Time Profile During 72 Hours After Dose (AUC72h).

The Maximum Serum Concentration (Cmax).

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.

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Pharmaceutical Research Associates Group B.V (PRA), Zuidlaren 9471 GP, Netherlands
Additional Information

Starting date: May 2013
Last updated: October 23, 2014

Page last updated: August 23, 2015

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