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Phase I Pharmacokinetic Study (SALBLOCK)

O

Orion Pharma

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteer Study

Treatments

Drug: salmeterol / fluticasone propionate

Study type

Interventional

Funder types

Industry

Identifiers

NCT01564199
3106006

Details and patient eligibility

About

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).

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Treatment A
Experimental group
Description:
Salmeterol/fluticasone propionate with concomitant charcoal
Treatment:
Drug: salmeterol / fluticasone propionate
Treatment B
Experimental group
Description:
Salmeterol/fluticasone propionate without concomitant charcoal
Treatment:
Drug: salmeterol / fluticasone propionate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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