Clinical trial NCT01176851 (phase 1, status: completed)
Conditions: healthy
ICD codes: Z76.3, Z76.2
Drugs: glycopyrrolate, glycopyrrolate, glycopyrrolate
SMILES: C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1, C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1, C[N+]1(C)CCC(C1)OC(=O)C(O)(C1CCCC1)C1=CC=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          1. Males and females healthy volunteers aged 18-65 years;

          2. Written informed consent obtained before the first trial related activity.

          3. Able to understand the study procedures, the risks involved and ability to be trained
             to use the devices correctly.

          4. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;

          5. Non- or ex-smokers who smoked < 5 pack years;

          6. Good physical and mental status;

          7. Normal blood pressure and heart rate;

          8. Electrocardiogram (ECG)considered as normal;

          9. Results of laboratory tests within the normal ranges.

         10. Lung function measurements within the normal ranges.

        Exclusion Criteria:

          1. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before
             inhalation of the study medication;

          2. Pregnant or lactating women or women of childbearing potential, UNLESS they are using
             one or more of the acceptable methods of contraception. Male subjects not willing to
             use an acceptable method of contraception.

          3. Positive HIV1 or HIV2 serology;

          4. Positive results from the Hepatitis serology which indicates acute or chronic
             Hepatitis B or Hepatitis C;

          5. Unsuitable veins for repeated venipuncture;

          6. History of substance abuse or drug abuse within 12 months prior to screening visit or
             with a positive urine drug screen at screening;

          7. Clinically relevant abnormal laboratory values suggesting an unknown disease and
             requiring further clinical investigation;

          8. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal,
             endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with
             successful completion of this protocol;

          9. Participation in another clinical trial less than 8 weeks prior to inhalation of the
             study medication; participation in another clinical trial using radioactive material
             within 1 calendar year;

         10. History of hypersensitivity to M3 Antagonists or any of the excipients contained in
             any of the formulations used in the trial;

         11. Any drug treatment, including prescribed or OTC medicines as well as vitamins,
             homeopathic remedies etc, taken in the 14 days (2 months for enzyme-inducing or
             enzyme-inhibiting drugs e.g., glucocorticoids, phenobarbital, isoniazid) preceding the
             first intake of the study drug, with the exception of occasional paracetamol (maximum
             2 g per day with a maximum of 10 g per 14 days for mild non-excluding conditions).

         12. Treatment within the previous 3 months with any drug known to have a well defined
             potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole).

         13. Subjects who refuse to abstain from alcohol or caffeine containing foods or beverages
             or grapefruit containing foods or beverages from 48 hour prior to the first intake of
             study medication and for the entire duration of the study.

         14. Heavy caffeine drinker.