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Phase I Pharmacokinetic Study (SALBLOCK)

Sponsor
Orion Corporation, Orion Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01564199
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: salmeterol / fluticasone propionate
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Charcoal on Gastrointestinal Absorption of Salmeterol and Fluticasone Propionate.
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A

Salmeterol/fluticasone propionate with concomitant charcoal

Drug: salmeterol / fluticasone propionate
100/1000 μg oral capsule
Experimental: Treatment B

Salmeterol/fluticasone propionate without concomitant charcoal

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CRST (Clinical Research Services Turku) Turku Finland

Sponsors and Collaborators

  • Orion Corporation, Orion Pharma

Investigators

  • Principal Investigator: Mika Scheinin, MD, PhD, Clinical Research Services Turku Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01564199
Other Study ID Numbers:
  • 3106006
First Posted:
Mar 27, 2012
Last Update Posted:
Jun 26, 2012
Last Verified:
Mar 1, 2012
Additional relevant MeSH terms:
Fluticasone
Xhance
Salmeterol Xinafoate

Study Results

No Results Posted as of Jun 26, 2012