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Completed

NCT Number: NCT01953367

Bioequivalence and Safety of Vantobra and TOBI 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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Inamed GmbH

Gauting, 82131, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vantobra (tobramycin)

Drug

Inhalation

TOBI (tobramycin)

Drug

Inhalation

Primary outcomes

  1. 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

    Time frame: Day 1 and Day 7

    Plasma AUClast of tobramycin

  2. 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

    Time frame: Day 1 and Day 7

    Plasma Cmax of tobramycin

  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

    Time frame: Day 1 and Day 7

    tmax of tobramycin

Secondary outcomes

  1. Number of Adverse Events during the trial period

    Time frame: Adverse Events during the study period of max. 17 days

    Adverse events

Sponsors and collaborators

Lead sponsor

Pari Pharma GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 1, 2013
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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