Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase I Pharmacokinetic Study (SALBLOCK) (SALBLOCK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564199
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : June 26, 2012
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: salmeterol / fluticasone propionate Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : April 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine


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




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. [ Time Frame: 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. [ Time Frame: 24 hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564199


Locations
Layout table for location information
Finland
CRST (Clinical Research Services Turku)
Turku, Finland
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Layout table for investigator information
Principal Investigator: Mika Scheinin, MD, PhD Clinical Research Services Turku Finland
Layout table for additonal information
Responsible Party: Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier: NCT01564199    
Other Study ID Numbers: 3106006
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
Layout table for MeSH terms
Fluticasone
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action