Pharmacokinetic Interaction Study of Glycopyrrolate and Formoterol in Healthy Volunteers
TRIPLE 1
Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.
2 other identifiers
interventional
44
1 country
1
Brief Summary
This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2011
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedOctober 29, 2021
October 1, 2021
3 months
June 9, 2011
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Pharmacokinetics: formoterol and glyco AUC0-t
Area under the plasma concentration curve observed from administration up to the last measurable concentration.
from pre-dose to 32 hours after administration
Pharmacokinetics: formoterol and glyco Cmax
Maximum plasma concentration
from pre-dose to 32 hours after administration
Secondary Outcomes (6)
Additional pharmacokinetic variables
from pre-dose to 32 hours post dose
Serum potassium
From pre-dose to 24 hours after administration
Plasma glucose
from pre-dose to 24 hours after administration
Lung function
from pre-dose to 1 hour after administration
Vital signs
from pre-dose to 24 hours after administration
- +1 more secondary outcomes
Study Arms (4)
Treatment R2
ACTIVE COMPARATORTreatment R1
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORTreatment T
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Males and females healthy volunteers aged 18-65 years will be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Pharmacology Unit - SGS Life Science Services
Antwerp, Lange Beeldekensstraat 267, 2060, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lien Gheyle, MD
Clinical Pharmacology Unit at SGS Life Sciences - Antwerpen (Belgium)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
July 20, 2011
Study Start
May 1, 2011
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
October 29, 2021
Record last verified: 2021-10