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NCT03440164
Superior Silybin Bioavailability in Healthy Volunteers
trial testing Sylimarin and Sylibin in Liver Diseases in 24 participants. Completed in 15 December 2016.
8 December 2016
Quick facts
| Lead sponsor | Medica Sur Clinic & Foundation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 24 |
| Start date | 11 November 2016 |
| Primary completion | 8 December 2016 |
| Estimated completion | 15 December 2016 |
Drugs / interventions tested
- Sylimarin and Sylibin
Conditions studied
- Liver Diseases — all drugs for Liver Diseases →
- Chronic Liver Disease — all drugs for Chronic Liver Disease →
Sponsor
Medica Sur Clinic & Foundation
Who can join
Adults 18 to 50, any sex, with Liver Diseases or Chronic Liver Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Twenty-four healthy volunteers of both genders, aged 18 to 44 years old and body mass indexes between 18 to 27 kg/m2,were selected to participate in a two-way, balanced, prospective, blind, single-dose crossover study with a one-week wash-out period. It was assessed that volunteers were free from significant cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and hematological diseases. The volunteers clinical evaluation were determined by clinical examination, ECG, and the following laboratory tests: blood glucose, urea, creatinine, AST, ALT, GGT, alkaline phosphatase, total bilirubin and fractions, uric acid, total cholesterol, triglycerides, albumin and total protein, and routine urinalysis. All subjects were negative for HIV, HBV, and HCV.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Superior silybin bioavailability of silybin-phosphatidylcholine complex in oily-medium soft-gel capsules versus conventional silymarin tablets in healthy volunteers.
Méndez-Sánchez N, Dibildox-Martinez M, Sosa-Noguera J, Sánchez-Medal R, et al · · 2019 · cited 22× · PMID 30635055 · DOI 10.1186/s40360-018-0280-8 -
Silymarin and Silybin: Rejuvenating Traditional Remedies with Modern Delivery Strategies.
Li X, Zhu H, Wang Y, Zhang X, et al · · 2025 · PMID 41471139 · DOI 10.3390/pharmaceutics17121628
Verify or expand the search:
- PubMed search for NCT03440164
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Medica Sur Clinic & Foundation trials
Trials by the same sponsor.
- NCT05566548 — Role of Bilirubin Molecular Species in Hepatic Encephalopathy and Acute-on-chronic Liver Failure · 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 NCT03440164 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medica Sur Clinic & Foundation
- Last refreshed: 22 February 2018
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/NCT03440164.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing