Completed PHASE1 INTERVENTIONAL 2-arm NCT05913921

Bioequivalence of Amphotericin B Liposome for Injection

A Randomized, Open-label, Single-dose, Two-preparation, Two-period, Two-sequence Bioequivalence Study Between Amphotericin B Liposome for Injection and AmBisome® in Healthy Subjects

Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Conditions Bioequivalence

Interventions AmBisome Amphotericin B liposome for injection

Updated 4 times since 2023 Last updated: Sep 27, 2023 Started: Jun 2, 2023 Primary completion: Sep 1, 2023 Completion: Sep 1, 2023

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Bioequivalence and is currently completed. CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. leads this study, which shows 4 recorded versions since 2023 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

4 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Oct 2023 — Jul 2024 [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Jul 2023 — Oct 2023 [monthly]

Active Not Recruiting PHASE1

First recorded

Jun 2023

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Data source: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Haikou, China