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NCT01050751
Open-Label, Randomized, 2-Way Crossover Study To Estimate The Pharmacokinetics And Bioavailability Of Lersivirine (UK 453,061) Administered As A Single 750 Mg Tablet And 3 X 250 Mg Tablets In Healthy Subjects
Phase 1 trial testing Lersivirine in Healthy Volunteers in 12 participants. Completed in 1 March 2010.
1 March 2010
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 February 2010 |
| Primary completion | 1 March 2010 |
| Estimated completion | 1 March 2010 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Lersivirine — full drug profile →
- Lersivirine — full drug profile →
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
To estimate the bioavailability of 1 x 750 mg lersivirine tablet compared to 3 x 250 mg lersivirine tablets.
Time frame: 7 days
Sponsor's own description
This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg tablet is similar to 3 x 250 mg tablets (750 mg total).
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 NCT01050751
- 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 NCT01050751 (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 Pfizer
- Last refreshed: 8 March 2010
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/NCT01050751.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing