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Propranolol Enabling Study

Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: propranolol (Drug)

Phase: Phase 1

Status: Active, not recruiting

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD MDsc FFPM, Study Director, Affiliation: GlaxoSmithKline

Summary

Propranolol Enabling Study

Clinical Details

Official title: A Study to Optimise the Propranolol Block Model for Assessment of the Pharmacological Activity of Bronchodilators in Healthy Volunteers.

Study design: Prospective

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Healthy adult males 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:

- who have 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

Locations and Contacts

GSK Clinical Trials Call Center, London HA13UJ, United Kingdom
Additional Information

Starting date: August 2007
Last updated: October 23, 2007

Page last updated: June 20, 2008

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