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NCT03302065
Phase I Randomised, Four-period Balanced Incomplete Block Design Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With One Reference Product
Phase 1 trial testing Tiotropium in Healthy in 38 participants. Completed in 1 January 2017.
1 September 2016
Quick facts
| Lead sponsor | Solventum US LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 38 |
| Start date | 1 May 2016 |
| Primary completion | 1 September 2016 |
| Estimated completion | 1 January 2017 |
Drugs / interventions tested
- Tiotropium — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Solventum US LLC — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Cmax
Time frame: 48 hours
maximum plasma concentration
Sponsor's own description
The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03302065
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tiotropium
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- NCT05083429 — Replication of the POET-COPD Trial in Healthcare Claims Data · completed
- NCT04249310 — Early Intervention Efficacy in COPD · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Solventum US LLC trials
Trials by the same sponsor.
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- NCT05361746 — Scotchbond Universal Plus Compared to Scotchbond Universal With Filtek Universal Restorative to Restore Class V NCCLs · NA · active not recruiting
- NCT05248204 — Scotchbond Universal Plus Compared to Scotchbond Universal for Posterior Class I & II Restorations With Filtek Universal · NA · completed
- NCT04906512 — Comparing CHG I.V. Securement Dressing With Transparent Dressing for Evaluation of Antimicrobial Efficacy · NA · terminated
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 NCT03302065 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Solventum US LLC
- Last refreshed: 27 November 2024
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/NCT03302065.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing