Phase I Pharmacokinetic Study (SALBLOCK)

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: Drug: salmeterol / fluticasone propionate

• Registration Number: NCT01564199
• Lead Sponsor: Orion Corporation, Orion Pharma

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-03
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-27
• Study Start: 2012-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-25
• Last Update Posted: 2012-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Healthy males and females aged 18-60
• Normal weight at least 50 kg

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment B	salmeterol / fluticasone propionate	Salmeterol/fluticasone propionate without concomitant charcoal
Treatment A	salmeterol / fluticasone propionate	Salmeterol/fluticasone propionate with concomitant charcoal

Primary Outcome Measures

Name	Time	Method
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.	24 hours	The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover study design.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CRST (Clinical Research Services Turku); 🇫🇮 Turku, Finland