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UNKNOWNPHASE1

Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets

To Evaluate the Tolerability and Pharmacokinetics of GST-HG141 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

NCT04386915•Fujian Cosunter Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

Summary

Detailed Description

This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies. To evaluate the tolerance of GST-HG141 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG141 pharmacokinetics.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
•2. Ability to complete research in accordance with test plan requirements;
•3. Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
•4. Male and female healthy subjects aged 18 to 55 years (including 18 and 55 years old);
•5. Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 \~ 28 kg / m2 (including critical value);
•6. Physical examination, normal or abnormal vital signs have no clinical significance.

Exclusion Criteria

•1. Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
•2. Allergies (multiple drugs and food allergies);
•3. Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
•4. Blood donation or massive blood loss (\> 450 mL) within three months before screening;
•5. Take any drug that changes the activity of liver enzymes 28 days before screening;
•6. Took any prescription drugs, over-the-counter drugs, any vitamin products, or herbs within 14 days before screening;
•7. Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening;
•8. Combined with inhibitors or inducers of CYP3A4, such as itraconazole, ketoconazole, etc.;
•9. Major changes in diet or exercise habits recently;
•10. Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
+12 more criteria

Locations (1)

The first hospital of Jilin University

Changchun, Jilin, China

Key Dates

Start Date

May 18, 2020

Primary Completion Date

May 30, 2021

Completion Date

August 1, 2021

Last Updated

June 4, 2020

Enrollment

104

ESTIMATED participants

Conditions

Hepatitis B

Interventions

GST-HG141 tablets

DRUG

Placebo

DRUG

Contacts

Yanan Tang, MD

CONTACT

+86 13585734994 annie_tyn@163.com

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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: June 4, 2020Data 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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets

Inclusion Criteria

Exclusion Criteria

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