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NCT03791463
Effect of Food on Pharmacokinetics of Salvianolic Acid A in Healthy Subjects
Phase 1 trial testing salvianolic acid A in Healthy in 14 participants. Status unknown.
1 January 2019
Quick facts
| Lead sponsor | Peking University First Hospital |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 14 |
| Start date | 20 December 2018 |
| Primary completion | 1 January 2019 |
| Estimated completion | 1 January 2019 |
| Sites | 1 location across China |
Drugs / interventions tested
- salvianolic acid A — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Peking University First Hospital
Who can join
Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is an open-label, randomized, cross-over design with two single-dose treatment periods and a washout of at least 3\~5 days in between each treatment visit. The study period consists of 3 visits to the study centre: Visit 1 (enrolment), Visit 2 (first single-dose treatment), Visit 3 (second single-dose treatment). Target subject population is healthy subjects aged 18-45 years. Following an overnight fast of at least 10 hours, a single dose of 90mg salvianolic acid A will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03791463
- Europe PMC full search
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Related trials
Other trials of salvianolic acid A
Trials testing the same drug.
- NCT03908242 — Phase I Study of Continuous Administration of Salvianolic Acid A Tablet · Phase 1 · unknown
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Other Peking University First Hospital trials
Trials by the same sponsor.
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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 NCT03791463 (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 Peking University First Hospital
- Last refreshed: 2 January 2019
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/NCT03791463.
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