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NCT03734354
The Pharmacokinetics, Tolerability and Safety of Brexpiprazole in Healthy Chinese Subjects
Phase 1 trial testing Brexpiprazole in Health in 30 participants. Completed in 18 May 2020.
18 May 2020
Quick facts
| Lead sponsor | Otsuka Beijing Research Institute |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 30 |
| Start date | 7 April 2019 |
| Primary completion | 18 May 2020 |
| Estimated completion | 18 May 2020 |
| Sites | 1 location across China |
Drugs / interventions tested
- Brexpiprazole (BREXPIPRAZOLE) — full drug profile →
Conditions studied
- Health — all drugs for Health →
Sponsor
Otsuka Beijing Research Institute
Who can join
Adults 18 to 45, any sex, with Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a single-center, open-label study evaluating the pharmacokinetics, tolerability and safety of single dose oral brexpiprazole tablets in healthy Chinese subjects. A total of 30 healthy adult subjects are to be enrolled into the study. Three dose groups will be set up, with about 10 subjects in each dose group. Subjects will enter 1 mg, 2 mg and 4 mg dose groups in sequence.
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 NCT03734354
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05169268 — Real-life Assessment of Abilify Maintena + Rexult in Schizophrenia · recruiting
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Other recruiting trials for Health
Currently open trials in the same condition.
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Other Otsuka Beijing Research Institute trials
Trials by the same sponsor.
- NCT06091267 — PK/Efficacy Bridging Study of ASTX727 in Chinese Subjects With Myelodysplastic Syndromes · Phase 1, PHASE2 · active not recruiting
- NCT05923892 — Phase II Clinical Trial of OPS-2071 in the Treatment of Irritable Bowel Syndrome of Diarrhea Type · Phase 2 · completed
- NCT05650320 — To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD · Phase 3 · completed
- NCT05667623 — To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD · Phase 3 · completed
- NCT07105124 — Safety and Tolerability, and PK of Sibeprenlimab in Chinese Healthy Subject · 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 NCT03734354 (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 Otsuka Beijing Research Institute
- Last refreshed: 1 November 2023
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/NCT03734354.
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