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Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Vantobra (tobramycin)
TOBI (tobramycin)
Sponsored by
Pari Pharma GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cystic Fibrosis focused on measuring Bioequivalence, AUC, Cmax

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Inamed GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Vantobra; Treatment A

TOBI; Treatment B

Arm Description

Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution

TOBI, 300 mg tobramycin/5 mL nebulizer solution

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Number of Adverse Events during the trial period
Adverse events

Full Information

First Posted
September 4, 2013
Last Updated
April 24, 2014
Sponsor
Pari Pharma GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01953367
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pari Pharma GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Bioequivalence, AUC, Cmax

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vantobra; Treatment A
Arm Type
Experimental
Arm Description
Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution
Arm Title
TOBI; Treatment B
Arm Type
Active Comparator
Arm Description
TOBI, 300 mg tobramycin/5 mL nebulizer solution
Intervention Type
Drug
Intervention Name(s)
Vantobra (tobramycin)
Intervention Description
Inhalation
Intervention Type
Drug
Intervention Name(s)
TOBI (tobramycin)
Intervention Description
Inhalation
Primary Outcome Measure Information:
Title
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
Description
Plasma AUClast of tobramycin
Time Frame
Day 1 and Day 7
Title
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
Description
Plasma Cmax of tobramycin
Time Frame
Day 1 and Day 7
Title
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
Description
tmax of tobramycin
Time Frame
Day 1 and Day 7
Secondary Outcome Measure Information:
Title
Number of Adverse Events during the trial period
Description
Adverse events
Time Frame
Adverse Events during the study period of max. 17 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wolgang Timmer, MD
Organizational Affiliation
Inamed GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inamed GmbH
City
Gauting
ZIP/Postal Code
82131
Country
Germany

12. IPD Sharing Statement

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Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

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