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Trial record 21 of 186 for:    GLYCOPYRROLATE

Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers (Gly1)

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ClinicalTrials.gov Identifier: NCT01176851
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : October 27, 2010
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.

Tracking Information
First Submitted Date  ICMJE August 5, 2010
First Posted Date  ICMJE August 6, 2010
Last Update Posted Date October 27, 2010
Study Start Date  ICMJE July 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
Plasma and urine pharmacokinetics of glycopyrrolate [ Time Frame: over 24 h post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01176851 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 5, 2010)
  • Lung function parameters [ Time Frame: over 24 h post dose ]
  • Cardiovascular parameters [ Time Frame: over 24 h post dose ]
  • Clinical chemistry and haematology, urinalysis [ Time Frame: over 24 h post dose ]
  • Adverse Events [ Time Frame: during the whole study period ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biopharmaceutical Study of Glyco pMDI With or Without Charcoal Block vs IV Bolus in Healthy Volunteers
Official Title  ICMJE Pharmacokinetic, Randomized, Open-label, Single-dose, 3-way Cross-over Study of Intravenous and Inhaled Glycopyrrolate With or Without Charcoal Block Ingestion in Healthy Volunteers.
Brief Summary The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Glycopyrrolate
    Single administration of Glyco pMDI 100 µg
    Other Name: CHF 5259
  • Drug: Glycopyrrolate
    Single administration of Glyco pMDI 100 µg after charcoal ingestion
    Other Name: CHF 5259
  • Drug: Glycopyrrolate
    Single intravenous injection of glycopyrrolate 100 µg
    Other Name: Robinul Injection
Study Arms  ICMJE
  • Experimental: Glyco pMDI
    Glyco pMDI 100 µg
    Intervention: Drug: Glycopyrrolate
  • Experimental: Glyco pMDI Charcoal
    Glyco pMDI 100 µg + charcoal block
    Intervention: Drug: Glycopyrrolate
  • Active Comparator: Glyco IV injection
    Glyco solution for injection 100 µg
    Intervention: Drug: Glycopyrrolate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: August 5, 2010)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01176851
Other Study ID Numbers  ICMJE CCD-0915-PR-0031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martine Cartier, Head of Clinical Operations, Chiesi Farmaceutici SpA
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dave Singh, MD Medicines Evaluation Unit
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP