CompletedPhase 1

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

United Kingdom20 participantsStarted 2010-07

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males and females healthy volunteers aged 18-65 years;
✓. Written informed consent obtained before the first trial related activity.
✓. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
✓. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
✓. Non- or ex-smokers who smoked \< 5 pack years;
✓. Good physical and mental status;
✓. Normal blood pressure and heart rate;
✓. Electrocardiogram (ECG)considered as normal;

✕. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
✕. 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.
✕. Positive HIV1 or HIV2 serology;
✕. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
✕. Unsuitable veins for repeated venipuncture;
✕. History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
✕. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
✕. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;

Plasma and urine pharmacokinetics of glycopyrrolate

Timeframe: over 24 h post dose

NCT IDNCT01176851

SponsorChiesi Farmaceutici S.p.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Males and females healthy volunteers aged 18-65 years;
✓. Written informed consent obtained before the first trial related activity.
✓. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly.
✓. Body Mass Index (BMI) between 18.0 and 32.0 kg/m2;
✓. Non- or ex-smokers who smoked \< 5 pack years;
✓. Good physical and mental status;
✓. Normal blood pressure and heart rate;
✓. Electrocardiogram (ECG)considered as normal;

✕. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication;
✕. 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.
✕. Positive HIV1 or HIV2 serology;
✕. Positive results from the Hepatitis serology which indicates acute or chronic Hepatitis B or Hepatitis C;
✕. Unsuitable veins for repeated venipuncture;
✕. History of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening;
✕. Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
✕. Clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol;