Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01953367
• Date of registration: 04/09/2013
• Prospective Registration: No
• Primary sponsor: Pari Pharma GmbH
• Public title: Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
• Scientific title: Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects
• Date of first enrolment: September 2013
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01953367
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 1

Countries of recruitment

Germany

Contacts

• Name: Wolgang Timmer, MD
• Affiliation: Inamed GmbH

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female healthy subjects of any ethnic origin

- Aged between 18 and 50 years of age

- Body weight of =50 kg and body mass index (BMI) between 18.5 and 29 kg/m2

- FEV1 > 90% of predicted

- Able to demonstrate correct inhaler use

- Written informed consent

Exclusion Criteria:

- History of clinically relevant allergies or idiosyncrasies to tobramycin or any other
inactive ingredient(s) of the IMP

- Any history of drug hypersensitivity, asthma, urticaria, or other significant
allergic diathesis.

- Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal,
hematological, endocrinological, metabolic, neurological, psychiatric or other
diseases at screening

- Surgery of the gastrointestinal or respiratory tract which might interfere with drug
absorption

- History of malignancy within the past 5 years

- History of orthostatic hypotension, faintings or blackouts

- Acute or chronic viral, bacterial or fungal airway infections, including laryngeal
infections, mouth and throat infections, and hoarseness;

- Other clinically relevant chronic or acute infectious illnesses

- Clinical chemical, hematological or any other laboratory parameters clinically
relevant outside the normal range



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: TOBI (tobramycin)

Drug: Vantobra (tobramycin)

Primary Outcome(s)

To investigate the bioequivalence (in terms of relative systemic bioavailability based on pharmacokinetic plasma profiles) of Vantobra 170 mg/1.7 mL nebulizer solution as compared to TOBI 300 mg/5 mL nebulizer solution in healthy subjects [Time Frame: Day 1 and Day 7]

Secondary Outcome(s)

Number of Adverse Events during the trial period [Time Frame: Adverse Events during the study period of max. 17 days]

Secondary ID(s)

12012.102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors