Bioequivalence of Orfadin Suspension Compared to Orfadin Capsules, and the Effect of Food on the Bioavailability of the Suspension

Sobi

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Nitisinone, suspension; Drug: Nitisinone, capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682538

Sobi.NTBC-001

Details and patient eligibility

About

The study is primarily being performed in order to demonstrate bioequivalence between the Orfadin (nitisinone) suspension and the marketed capsule formulation. The study will also contain a comparison of the bioavailability of the suspension given with food and on an empty stomach.

Full description

This is an open, randomized 3-way crossover study in 12 healthy volunteers. Subjects will receive single oral 30-mg doses of nitisinone as a suspension (fasting and with food) and as hard gelatin capsules (fasting only). There will be a 2-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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers
• Age: 18-55 years, inclusive
• BMI: 18,5-30,0 kg/m2, inclusive

Exclusion criteria

• heavy smokers
• Consumption of more than 4 cups of coffee per day.
• History of drug and/or alcohol abuse.
• Positive drug screen or alcohol breath test.
• Positive screens for hepatitis B surface antigen, hepatitis C antibodies and human immunodeficiency virus (HIV) 1-2 antibodies.
• Enrollment in another concurrent clinical study
• Intake of an investigational medicinal product within three months prior to inclusion in this study.
• Donation of more than 50 mL of blood within 60 days prior to drug administration
• Donation of more than 1,5 liters of blood in the 10 months prior to first drug administration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

Orfadin capsules, fasting

Active Comparator group

Description:

Orfadin capsules, single dose, 30 mg

Treatment:

Drug: Nitisinone, capsule

Orfadin suspension, fasting

Experimental group

Description:

Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)

Treatment:

Drug: Nitisinone, suspension

Orfadin suspension, with food

Experimental group

Description:

Orfadin suspension 4mg/mL, single dose 30 mg (7,5 mL)

Treatment:

Drug: Nitisinone, suspension