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Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

P

Pari Pharma

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Vantobra (tobramycin)
Drug: TOBI (tobramycin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01953367
12012.102

Details and patient eligibility

About

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.

Enrollment

72 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Vantobra; Treatment A
Experimental group
Description:
Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution
Treatment:
Drug: Vantobra (tobramycin)
TOBI; Treatment B
Active Comparator group
Description:
TOBI, 300 mg tobramycin/5 mL nebulizer solution
Treatment:
Drug: TOBI (tobramycin)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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