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NCT01351129
A Phase 1, Single-Dose, Open-Label, Crossover Study To Estimate The Relative Bioavailability Of Two Controlled-Release Formulations Vs. An Immediate Release Formulation Of PF-04991532 In Healthy Adult Subjects
Phase 1 trial testing Formulation 1 in Healthy in 12 participants. Completed in 1 June 2011.
1 June 2011
Quick facts
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 12 |
| Start date | 1 May 2011 |
| Primary completion | 1 June 2011 |
| Estimated completion | 1 June 2011 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Formulation 1
- Formulation 2
- Formulation 3
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Pfizer — full company profile →
Who can join
Adults 21 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.
-
Area under the plasma concentration versus time profile (AUC)
Time frame: predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12,24,36,48 hrs postdose
Sponsor's own description
The primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability three different formulations of PF-04991532 in healthy adult subjects.
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 NCT01351129
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Formulation 1
Trials testing the same drug.
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Other recruiting trials for Healthy
Currently open trials in the same condition.
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Other Pfizer trials
Trials by the same sponsor.
- NCT04982848 — Korea Post Marketing Surveillance (PMS) Study of Talzenna® · not yet recruiting
- NCT06873191 — A Study to Learn More About Tukysa Once it is Out in the Korean Market · not yet recruiting
- NCT07497854 — A Study to Learn About the Study Medicine NURTEC® ODT 75 mg After it is Released Into the Markets in Korea · not yet recruiting
- NCT06507904 — A Study to Learn How Different Preparations of Osivelotor Taste and Enter the Blood With Food or Liquids or With an Anta · Phase 1 · not yet recruiting
- NCT06864585 — A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan · not yet recruiting
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 NCT01351129 (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: 5 July 2011
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/NCT01351129.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing