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NCT01899638
Pharmacokinetics Of Umeclidinium and Vilanterol in Healthy Chinese, a Randomized, Open Label, 3 Crossover Study.
Phase 1 trial testing UMEC/VI 125/25 mcg in Pulmonary Disease, Chronic Obstructive in 20 participants. Completed in 25 July 2013.
25 July 2013
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 20 May 2013 |
| Primary completion | 25 July 2013 |
| Estimated completion | 25 July 2013 |
| Sites | 1 location across China |
Drugs / interventions tested
- UMEC/VI 125/25 mcg — full drug profile →
- UMEC/VI 62.5/25 mcg — full drug profile →
- UMEC 125 mcg — full drug profile →
- UMEC 62.5 mcg — full drug profile →
- VI 25 mcg — full drug profile →
Conditions studied
- Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 45, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is to assess the pharmacokinetics (PK), safety and tolerability of UMEC (62.5µg and 125µg) and VI (25µg) as monotherapies and combinations in healthy Chinese subjects.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Pharmacokinetics and tolerability of inhaled umeclidinium and vilanterol alone and in combination in healthy Chinese subjects: a randomized, open-label, crossover trial.
Hu C, Jia J, Dong K, Luo L, et al · · 2015 · cited 12× · PMID 25816315 · DOI 10.1371/journal.pone.0121264 -
Evidence-based review of data on the combination inhaler umeclidinium/vilanterol in patients with COPD.
Albertson TE, Bowman WS, Harper RW, Godbout RM, et al · · 2019 · cited 3× · PMID 31239659 · DOI 10.2147/copd.s191845
Verify or expand the search:
- PubMed search for NCT01899638
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01899638 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 7 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01899638.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing