Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-25 @ 4:18 AM
NCT ID:
NCT00549120
Eligibility Criteria:
Inclusion Criteria:
* Healthy adult male or female aged between 18 and 50 years.
* Body mass index within the range 19-29.9 kilograms/metre2
* Forced Expiratory Volume in 1 second (FEV1) \>80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \> 0.7
* The subject has an increase in sGAW of \>% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening.
* Subject has an increase in sGaw of 25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening
* Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \< 10 pack years.
Exclusion criteria:
* A past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject
* History of respiratory disease
* Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening \>450msec on an individual ECG or a PR interval outside the range 120-210 msec
* Supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening
* Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study
* Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort)
* Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month
* Infected with the Hepatitis B, Hepatitis C, or HIV virus
* Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00549120
Study Brief:
Protocol Section:
NCT00549120