Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Vantobra (tobramycin); Drug: TOBI (tobramycin)

• Registration Number: NCT01953367
• Lead Sponsor: Pari Pharma GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-24
• Study First Posted: 2013-10-01
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vantobra; Treatment A	Vantobra (tobramycin)	Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution
TOBI; Treatment B	TOBI (tobramycin)	TOBI, 300 mg tobramycin/5 mL nebulizer solution

Primary Outcome Measures

Name	Time	Method
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	tmax of tobramycin

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events during the trial period	Adverse Events during the study period of max. 17 days	Adverse events

Trial Locations

Locations (1)

Inamed GmbH; 🇩🇪 Gauting, Germany