Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01288170
• Date of registration: 01/02/2011
• Prospective Registration: No
• Primary sponsor: Erempharma
• Public title: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®
• Scientific title: Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus®
• Date of first enrolment: February 2010
• Target sample size: 12
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01288170
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Behrouz Kassaï

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults and children aged 6 years old and more

- Male or female

- Patients with cystic fibrosis (positive sudoral test, Cl > 60 mmol/L)

- Followed in a CRCM (CF care centre)

- FEV1 =40%

- Informed consent collected from adults or parents or legal guardians and children.

- Affiliation to the National Health Insurance program (Sécurité sociale).

Exclusion Criteria:

- - renal insufficiency defined by a creatinine clearance level superior to 2 mg/dl

- recent pneumothorax, emphysema, punction or recent pleural biopsy, recent haemoptysis
superior to 60 ml within 30 days prior to randomization

- Acute pulmonary exacerbation pathology, according to conference of consensus (2002),
evaluated by :

Cough increase, Sputum increase, Decrease in tolerance to effort, Loss of weight, lack of
appetite, Deterioration of respiratory function,

- Medical history of intolerance, toxicity or allergy to tobramycine, hypersensitivity to
aminoside



Age minimum: 6 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Tobi Nebcinal

Drug: Nebcinal Tobi

Primary Outcome(s)

plasma Area under the curve from 0 to 8 hours of tobramycine after administration of the drug

Secondary ID(s)

RM/NEB-02/09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hopitaux de Lyon

University of Lyon