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Completed

NCT Number: NCT01564199

Phase I Pharmacokinetic Study (SALBLOCK)

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).

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRST (Clinical Research Services Turku)

Turku, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

salmeterol / fluticasone propionate

Drug

100/1000 μg oral capsule

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Acronym: SALBLOCK

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 27, 2012
Registry last updated
Jun 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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