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Tolerability & Pharmacokinetics of Ginkgolide B Injection: Single- and Multiple-Ascending Doses in Healthy Subjects

NCT07457008 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-03-09

No results posted yet for this study

Summary

To evaluate the safety and tolerability of multiple intravenous infusions of Ginkgolide B Injection in healthy Chinese participants, as well as to assess the pharmacokinetic (PK) characteristics following single and multiple doses.

Conditions

  • Healthy Volunteers

Interventions

DRUG

The 10mg dose group

The 10mg dose group was prepared with 375ml of 0.9% sodium chloride solution to form different dosage groups, an

DRUG

The 20mg dose group

The 20mg dose group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

DRUG

The 30mg dose group

The 30mg dose group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

OTHER

The Placebo group

The Placebo group was prepared with 375ml of 0.9% sodium chloride solution, and was instilled at the same rate of 50 drops/min for 7 consecutive days.

Sponsors & Collaborators

  • West China Second University Hospital

    lead OTHER

Principal Investigators

  • Qin Yu · China West China Second University Hospital Chengdu, China

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2021-09-03
Completion
2021-09-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07457008 on ClinicalTrials.gov