Phase I Pharmacokinetic Study (SALBLOCK)

Healthy Volunteer Study Clinical Trial

— SALBLOCK  

Official title:

Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564199
• Other study ID #: 3106006
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2012
• Last updated: June 25, 2012
• Start date: April 2012
• Est. completion date: June 2012

Study information

• Verified date: March 2012
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to assess the extent to which the charcoal prevents the absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy males and females aged 18-60

• Normal weight at least 50 kg

Exclusion Criteria:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.

• Any condition requiring concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.

• Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.

• Known hypersensitivity to the active substance(s) or to the excipients of the drug.

• Pregnant or lactating females.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• salmeterol / fluticasone propionate
100/1000 µg oral capsule

Locations

Country	Name	City	State
Finland	CRST (Clinical Research Services Turku)	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The pharmacokinetic parameter Area Under Curve (AUC) time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose.	The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover study design.	24 hours	No
Secondary	The pharmacokinetic variables Cmax and tmax time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose.		24 hours	No