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Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses
NCT01894386 · View on ClinicalTrials.gov ↗
Study Summary
This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram \[mcg\]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA). Subjects will receive each of the four treatments once, separated by a wash-out period of 7-21 days between doses in a four way crossover design. There will be 4 treatment periods in total. During each treatment period, subjects will attend the clinical unit on Day -1 for standard safety assessments in addition to familiarization with the inhaler. Each subject will remain resident in the unit until at least 24 hours after the dose given on Day 1. Following completion of all four treatment periods, a follow up visit will take place 7 to 21 days following the final dose of study medication.
Conditions Studied
Interventions
- DRUG FF 400 mcg
- DRUG UMEC 500 mcg
- DRUG UMEC 250 mcg
- DRUG VI 100 mcg
Study Locations (1)
Maryland
- GSK Investigational Site — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2013-07-15 |
| Est. Completion | 2013-09-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01894386
The ClinicalTrials.gov registry entry for NCT01894386 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 4 interventions — of which FF 400 mcg is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01894386 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01894386 about?
NCT01894386 is a clinical study titled "Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses". This study will evaluate the pharmacokinetics of FF, UMEC and VI administered from one inhaler (at two different strengths of UMEC (125 and 62.5microgram \[mcg\]) and FF/VI (ICS/LABA) and UMEC/VI (LAMA/LABA). Subjects will receive each of the four treatments once, separated by a wash-out period of ...
What is the current status of trial NCT01894386?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2013-07-15. Estimated completion is 2013-09-26.
What conditions does trial NCT01894386 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01894386?
The interventions under investigation include: FF 400 mcg (DRUG), UMEC 500 mcg (DRUG), UMEC 250 mcg (DRUG), VI 100 mcg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01894386?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01894386 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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