Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953367
• Other study ID #: 12012.102
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2013
• Last updated: April 24, 2014
• Start date: September 2013
• Est. completion date: November 2013

Study information

• Verified date: April 2014
• Source: Pari Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• Vantobra (tobramycin)
Inhalation
• TOBI (tobramycin)
Inhalation

Locations

Country	Name	City	State
Germany	Inamed GmbH	Gauting

Sponsors (1)

Lead Sponsor	Collaborator
Pari Pharma GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Number of Adverse Events during the trial period	Adverse events	Adverse Events during the study period of max. 17 days	Yes