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A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese Subjects

NCT07422142•Kunming Pharmaceuticals, Inc.

Summary

This is a single-center, double-blind study to evaluate the safety, tolerability, pharmacokinetics of Gastrodin Injection in healthy Subjects

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects must have a full understanding of the trial's purpose, nature, procedures, and potential adverse reactions, voluntarily consent to participate as subjects, sign the informed consent form prior to the initiation of any research procedures, be capable of effective communication with investigators, and understand and comply with all requirements of the study.
•2. Healthy male or female subjects aged 18 to 65 years (inclusive of boundary values), with a male-to-female ratio of 1:1.
•3. Male subjects with a body weight ≥ 50.0 kg and female subjects with a body weight ≥ 45.0 kg. body mass index (BMI) ranging from 19.0 to 26.0 kg/m² (inclusive of boundary values) .
•4. Subjects must have no fertility plans during the trial period and within 3 months after the final administration, voluntarily adopt effective contraceptive measures, and have no plans to donate sperm or eggs.

Exclusion Criteria

•1. Subjects who developed acute diseases within 2 weeks prior to screening, such as acute gastroenteritis, acute upper respiratory tract infection, acute appendicitis, etc.
•2. Subjects with a history of any clinically severe diseases or conditions that the investigator deems may interfere with the evaluation of the safety or pharmacokinetic properties of the investigational drug, including but not limited to diseases of the circulatory, respiratory, endocrine, nervous, digestive, urinary systems, as well as hematological, immunological, psychiatric, and metabolic diseases.
•3. Subjects who underwent major surgery within 6 months prior to screening, or plan to undergo surgery during the study period or within 1 month after the trial completion.
•4. Subjects with an allergic diathesis (known hypersensitivity to two or more drugs) or known hypersensitivity to Gastrodin Injection and its related excipients.
•5. Subjects who donated blood within 3 months prior to screening, lost a total of ≥ 400 mL of blood due to blood donation or other causes (excluding normal menstrual blood loss in females) within 6 months prior to screening, or have a history of unexplained abnormal bleeding .
•6. Subjects who cannot tolerate venipuncture, indwelling needles or have a history of trypanophobia or hematophobia.
•7. Subjects with special dietary requirements who are unable to comply with the unified diet.
•8. Subjects who participated in other clinical trials and received investigational drugs or devices within 3 months prior to screening (Note: The end time is defined as the date of the last visit for trial discharge).
•9. Subjects who received live attenuated vaccine within 2 weeks prior to screening or require live attenuated vaccine during the trial period.
•10. Subjects who used any medications (including prescription drugs, nonprescription drugs, and Chinese herbal medicines) within 2 weeks prior to screening; Subjects who have consumed strong tea, beverages containing caffeine or alcohol or pomelos, grapefruits and their juices which affect drug metabolism, within 48 hours prior to screening.
+10 more criteria

Locations (1)

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

March 1, 2026

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

February 19, 2026

Enrollment

ESTIMATED participants

Conditions

Delirium

Interventions

gastrodin injection；placebo

DRUG

gastrodin injection；placebo

DRUG

Contacts

Duo Gao, bachelor

CONTACT

0871-68319868-3052 GAODUO5@kpc.com.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of Gastrodin Injection in Healthy Chinese Subjects

Inclusion Criteria

Exclusion Criteria

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