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NCT05788913
Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Subcutaneous Administration
Phase 1 trial testing Heparin in Anticoagulant in 68 participants. Status unknown.
30 June 2023
Quick facts
| Lead sponsor | Blau Farmaceutica S.A. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 68 |
| Start date | 1 June 2023 |
| Primary completion | 30 June 2023 |
| Estimated completion | 30 September 2023 |
Drugs / interventions tested
- Heparin (HEPARIN) — full drug profile →
Conditions studied
- Anticoagulant — all drugs for Anticoagulant →
Sponsor
Blau Farmaceutica S.A. — full company profile →
Who can join
Adults 18 to 55, any sex, with Anticoagulant. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Experimental Drug: Porcine sodium heparin, injectable solution - 5,000 IU/ 0.25 mL; Blau Farmacêutica S/A. Comparator Drug: Heparin Sodium Injection, USP, injectable solution - 5,000 IU/ 0.5 mL; Fresenius Kabi Lake Zurich. Evaluate the equivalence in terms of pharmacodynamics of heparin sodium (test product) and Heparin Sodium Injection, USP (comparator product). The clinical trial will last approximately 08 weeks and the study population will consist of 68 healthy research participants, 34 women and 34 men
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05788913
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials testing the same drug.
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Other recruiting trials for Anticoagulant
Currently open trials in the same condition.
- NCT04257487 — Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study) · Phase 3 · recruiting
- NCT04010955 — Adding Antiplatelet During Edoxaban Treatment in Stroke Patients With Non-valvular Atrial Fibrillation (ADD-ON) · active not recruiting
Other Blau Farmaceutica S.A. trials
Trials by the same sponsor.
- NCT05788900 — Evaluation of the Pharmacodynamics of a Heparin With Its Biological Comparator, Intravenous Administration · 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 NCT05788913 (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 Blau Farmaceutica S.A.
- Last refreshed: 29 March 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/NCT05788913.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing