NCT01953367

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

September 4, 2013

Last Update Submit

April 24, 2014

Conditions

Cystic Fibrosis

Keywords

BioequivalenceAUCCmax

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Number of Adverse Events during the trial period

    Adverse Events during the study period of max. 17 days

Study Arms (2)

Vantobra; Treatment A

EXPERIMENTAL

Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution

Drug: Vantobra (tobramycin)

TOBI; Treatment B

ACTIVE COMPARATOR

TOBI, 300 mg tobramycin/5 mL nebulizer solution

Drug: TOBI (tobramycin)

Interventions

Vantobra (tobramycin)DRUG

Inhalation

Vantobra; Treatment A
TOBI (tobramycin)DRUG

Inhalation

TOBI; Treatment B

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inamed GmbH

Gauting, 82131, Germany

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Tobramycin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Wolgang Timmer, MD

    Inamed GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2013

First Posted

October 1, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

DE(1)