Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01953367

Enrollment

Registered

2013-10-01

Start date

2013-09-30

Completion date

2013-11-30

Last updated

2014-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

Bioequivalence, AUC, Cmax

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.

Interventions

DRUGVantobra (tobramycin)

Inhalation

DRUGTOBI (tobramycin)

Inhalation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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	Day 1 and Day 7	Plasma AUClast of tobramycin

Secondary

Measure	Time frame	Description
Number of Adverse Events during the trial period	Adverse Events during the study period of max. 17 days	Adverse events

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026