Respiratory System Clinical Trial
Official title:
Non-blinded, Single Dose, Single Centre Trial to Assess the Pulmonary Deposition as Well as Pharmacokinetics, Safety and Tolerability of 99mTc Labeled Ciprofloxacin When Delivered as a Single Dose From a Dry Powder Inhaler to Healthy Subjects With and Without Charcoal Block and Patients Suffering From Bronchiectasis and COPD
The purpose of this study is to characterize variability and extent of the deposition of
ciprofloxacin in the respiratory tract of healthy subjects in comparison to patients with
chronic lung diseases after inhalation of a single 50 mg dry powder dose containing 32 mg
active substance. In addition the safety and pharmacokinetics of ciprofloxacin will be
evaluated. In this study the radiolabeled substance will be administered and scintigraphy
imaging techniques will be used to demonstrate the lung deposition visually. In the healthy
subjects an additional pharmacokinetic method is used to calculate lung deposition
indirectly based on pharmacokinetic data derived from plasma. For this purpose they will
inhale at a separate occasion another dose of ciprofloxacin after having ingested activated
charcoal. The latter serves to bind ciprofloxacin which is swallowed down during the
inhalation maneuver in the gastrointestinal (GI) tract, thus preventing its uptake into the
blood (charcoal block). Safety investigations will focus on local tolerability in the lung.
Pharmacokinetics is to see how the body absorbs, distributes, breaks down and gets rid of
the study drug.
Results from this study will be used to show how the drug is distributed in the human lung.
n/a
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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