Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

NCT ID: NCT01953367

Last Updated: 2014-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-11-30

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Vantobra; Treatment A

Vantobra, 170 mg tobramycin/1.7 mL nebulizer solution

Group Type: EXPERIMENTAL

Vantobra (tobramycin)

Intervention Type: DRUG

Inhalation

TOBI; Treatment B

TOBI, 300 mg tobramycin/5 mL nebulizer solution

Group Type: ACTIVE_COMPARATOR

TOBI (tobramycin)

Intervention Type: DRUG

Inhalation

Interventions

Vantobra (tobramycin)

Inhalation

Intervention Type: DRUG

TOBI (tobramycin)

Inhalation

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pari Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wolgang Timmer, MD

Role: PRINCIPAL_INVESTIGATOR

Inamed GmbH

Locations

Inamed GmbH

Gauting, , Germany

Countries

Germany

Other Identifiers

12012.102

Identifier Type: -

Identifier Source: org_study_id