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NCT00796029
Plasma Concentrations, Metabolism and Excretion of 14C-paliperidone After a Single Oral Dose in Healthy Male Subjects
Phase 1 trial testing 14C-paliperidone in Schizophrenia in 5 participants. Completed in 1 July 2003.
Quick facts
| Lead sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 1 July 2003 |
| Estimated completion | 1 July 2003 |
Drugs / interventions tested
- 14C-paliperidone — full drug profile →
Conditions studied
- Schizophrenia — all drugs for Schizophrenia →
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full company profile →
Who can join
Adults 40 to 60, male only, with Schizophrenia. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
- To investigate the metabolic pathways of paliperidone and excretion of paliperidone and its metabolites in healthy adult male volunteers,both poor and extensive metabolizers for CYP2D6,after administration of a single 1 mg oral dose of 14C paliperidone
Sponsor's own description
The purposes of this study are to investigate the metabolic pathways of paliperidone and excretion of paliperidone and its metabolites in healthy adult male volunteers, both CYP2D6 poor and extensive metabolizers, after administration of a single 1-mg oral dose of 14C-paliperidone, to evaluate the safety and tolerability of paliperidone, and to determine the relationship between genotypes (CYP2D6, CYP3A4, CYP3A5, UGT1A1, and UGT1A6) and exposure to paliperidone and its metabolites.
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 NCT00796029
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other Johnson & Johnson Pharmaceutical Research & Development, L.L.C. trials
Trials by the same sponsor.
- NCT04330248 — A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants · Phase 1 · completed
- NCT01094262 — A Safety and Tolerability Study of JNJ-42160443 in Patients With Moderate to Severe, Chronic Knee Pain From Osteoarthrit · Phase 2 · terminated
- NCT01060254 — A Study to Evaluate the Pain Relieving Effects, Safety, and Tolerability of JNJ-42160443 for the Relief of Bladder Pain · Phase 2 · terminated
- NCT00973141 — A Dose-ranging Study of the Safety and Effectiveness of JNJ-42160443 as add-on Treatment in Patients With Osteoarthritis · Phase 2 · terminated
- NCT01756404 — Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy · Phase 1 · completed
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 NCT00796029 (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 Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Last refreshed: 6 June 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/NCT00796029.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing