Phase I Pharmacokinetic Study (SALBLOCK)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01564199

Acronym

SALBLOCK

Enrollment

Registered

2012-03-27

Start date

2012-04-30

Completion date

2012-06-30

Last updated

2012-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer Study

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).

Interventions

DRUGsalmeterol / fluticasone propionate

100/1000 μg oral capsule

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026