Clinical trial NCT01953367: Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects
Official title: Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: Bioequivalence
AUC
Cmax
Lead sponsor: Pari Pharma GmbH
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.

Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Day 1 and Day 7
measure: 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
timeFrame: Day 1 and Day 7
measure: 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
timeFrame: Day 1 and Day 7
Secondary outcomes:
measure: Number of Adverse Events during the trial period
timeFrame: Adverse Events during the study period of max. 17 days
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: Inamed GmbH
Study officials:
affiliation: Inamed GmbH
name: Wolgang Timmer, MD
role: PRINCIPAL_INVESTIGATOR
References: