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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01176851
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : October 27, 2010
Information provided by:
Chiesi Farmaceutici S.p.A.

Brief Summary:
The purpose of this study is to investigate the pharmacokinetics, the absolute bioavailability and the lung bioavailability of inhaled Glyco pMDI.

Condition or disease Intervention/treatment Phase
Healthy Drug: Glycopyrrolate Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : July 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Glyco pMDI
Glyco pMDI 100 µg
Drug: Glycopyrrolate
Single administration of Glyco pMDI 100 µg
Other Name: CHF 5259

Experimental: Glyco pMDI Charcoal
Glyco pMDI 100 µg + charcoal block
Drug: Glycopyrrolate
Single administration of Glyco pMDI 100 µg after charcoal ingestion
Other Name: CHF 5259

Active Comparator: Glyco IV injection
Glyco solution for injection 100 µg
Drug: Glycopyrrolate
Single intravenous injection of glycopyrrolate 100 µg
Other Name: Robinul Injection

Primary Outcome Measures :
  1. Plasma and urine pharmacokinetics of glycopyrrolate [ Time Frame: over 24 h post dose ]

Secondary Outcome Measures :
  1. Lung function parameters [ Time Frame: over 24 h post dose ]
  2. Cardiovascular parameters [ Time Frame: over 24 h post dose ]
  3. Clinical chemistry and haematology, urinalysis [ Time Frame: over 24 h post dose ]
  4. Adverse Events [ Time Frame: during the whole study period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01176851

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United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
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Principal Investigator: Dave Singh, MD Medicines Evaluation Unit

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Responsible Party: Martine Cartier, Head of Clinical Operations, Chiesi Farmaceutici SpA Identifier: NCT01176851    
Other Study ID Numbers: CCD-0915-PR-0031
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: October 27, 2010
Last Verified: October 2010
Keywords provided by Chiesi Farmaceutici S.p.A.:
None (study in healthy volunteers)
Additional relevant MeSH terms:
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Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Protective Agents