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NCT06813807
A Comparative Study of the Pharmacokinetic Profiles of Timolol Maleate Ophthalmic Gel With Timolol Maleate Gel
Phase 1 trial testing 0.5% TM in Healthy Subjects in 18 participants. Completed in 5 July 2024.
5 July 2024
Quick facts
| Lead sponsor | Auson Pharmaceuticals Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 18 |
| Start date | 15 June 2024 |
| Primary completion | 5 July 2024 |
| Estimated completion | 5 July 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- 0.5% TM — full drug profile →
Conditions studied
- Healthy Subjects — all drugs for Healthy Subjects →
Sponsor
Auson Pharmaceuticals Inc. — full company profile →
Who can join
Adults 18 to 50, any sex, with Healthy Subjects. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this clinical trial is: 1)To evaluate the pharmacokinetic profiles and safety of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects after multiple dosing; 2)To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% Timolol Maleate Gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% Timolol Maleate Ophthalmic Gel Forming Solution in healthy adult subjects. The main questions aim to answer are: * Pharmacokinetic (PK) profiles of healthy adult subjects * Safety Evaluation * To compare the systemic exposure (Cmax,ss and AUCss) of 0.5% timolol maleate gel in subjects with proliferating superficial infantile hemangioma (completed) with that of 0.5% timolol maleate ophthalmic gel forming solution in healthy adult subjects.
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 NCT06813807
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Other Auson Pharmaceuticals Inc. trials
Trials by the same sponsor.
- NCT06677853 — Timolol Maleate Gel for the Treatment of Infantile Hemangioma · Phase 2, PHASE3 · completed
- NCT06824948 — Evaluate the Safety, Tolerance, and Pharmacokinetic Profiles of Timolol Maleate Gel · 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 NCT06813807 (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 Auson Pharmaceuticals Inc.
- Last refreshed: 7 February 2025
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/NCT06813807.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing