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NCT03112148
PK Study in Adult Healthy Volunteers to Assess QD Dosing With the Selected Age-appropriate MR Formulations
Phase 1 trial testing 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution in Healthy in 24 participants. Completed in 15 November 2017.
15 November 2017
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 11 September 2017 |
| Primary completion | 15 November 2017 |
| Estimated completion | 15 November 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 10 mg dose MR formulations,10 mg dose of tofacitinib IR solution — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — full company profile →
Who can join
Adults 18 to 55, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 1, randomized, open label, 4-period, 6-sequence, partial cross-over, single-dose study to evaluate the PK of age-appropriate tofacitinib MR formulations (release rates: MR-Slow, MR-Moderate, and MR-Fast) compared to tofacitinib IR solution under fasting conditions. The effect of food on the PK of MR-Slow and MR-Fast will also be assessed.
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 NCT03112148
- 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 NCT03112148 (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: 23 January 2018
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/NCT03112148.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing