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NCT04463173
Food Effect Study of Anaprazole in Healthy Chinese Subjects
Phase 1 trial testing Anaprazole in Healthy Male Volunteers in 14 participants. Completed in 2 July 2015.
2 July 2015
Quick facts
| Lead sponsor | Sihuan Pharmaceutical Holdings Group Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 16 June 2015 |
| Primary completion | 2 July 2015 |
| Estimated completion | 2 July 2015 |
Drugs / interventions tested
- Anaprazole — full drug profile →
- Anaprazole — full drug profile →
Conditions studied
- Healthy Male Volunteers — all drugs for Healthy Male Volunteers →
Sponsor
Sihuan Pharmaceutical Holdings Group Ltd. — full company profile →
Who can join
Adults 18 to 45, male only, with Healthy Male Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7). 2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral administration before breakfast, the other is oral administration 30 minutes after breakfast with high fat food.
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 NCT04463173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Healthy Male Volunteers
Currently open trials in the same condition.
- NCT07479745 — Study to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]GRT6019 · Phase 1 · recruiting
Other Sihuan Pharmaceutical Holdings Group Ltd. trials
Trials by the same sponsor.
- NCT04622072 — XZP-5809-TT1 Tablets in Patients With T790M Mutation-positive Locally Advanced or Metastatic Non-small Cell Lung Cancer · Phase 1 · terminated
- NCT04476394 — Open-label Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of [14C]-20 mg/ · Phase 1 · unknown
- NCT04444011 — Pharmacokinetic Interactions of Quadruple Therapy With Anaprazole/Amoxicilin/Clarithromycin/Bismuth · Phase 1 · unknown
- NCT04215653 — A Phase 3 Randomised Controlled Trial to Evaluate Efficacy and Safety of Anaprazole in Patients With Duodenal Ulcers. · Phase 3 · unknown
- NCT04200261 — Multiple-dose Tolerability and Pharmacokinetic Studies of Benapenem in Clinical Healthy Subjects · Phase 1 · unknown
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 NCT04463173 (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 Sihuan Pharmaceutical Holdings Group Ltd.
- Last refreshed: 9 July 2020
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/NCT04463173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing