Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Drug: Vantobra (tobramycin); Drug: TOBI (tobramycin)

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Gauting, Germany, 82131
    • Inamed GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vantobra; Treatment A; Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution	Drug: Vantobra (tobramycin); Inhalation
Active Comparator: TOBI; Treatment B; TOBI, 300 mg tobramycin/5 mL nebulizer solution	Drug: TOBI (tobramycin); Inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Plasma AUClast of tobramycin	Day 1 and Day 7
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	Plasma Cmax of tobramycin	Day 1 and Day 7
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	tmax of tobramycin	Day 1 and Day 7

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Pari Pharma GmbH
• Investigators: Principal Investigator: Wolgang Timmer, MD, Inamed GmbH

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): October 1, 2013

Study Record Updates

• Last Update Posted (Estimate): April 25, 2014
• Last Update Submitted That Met QC Criteria: April 24, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Bioequivalence; AUC; Cmax
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Cystic Fibrosis; Anti-Infective Agents; Anti-Bacterial Agents; Tobramycin
• Other Study ID Numbers: 12012.102