Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

Pari Pharma

Status and phase

Completed

Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Vantobra (tobramycin)

Drug: TOBI (tobramycin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01953367

12012.102

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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