A Study of the Pharmacokinetics of ASC09F in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-09

Study Completion Date

2020-12-07

Brief Summary

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The objective of this study is to evaluate the pharmacokinetic parameters of ASC09F in healthy subjects after multiple oral dosing.

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Detailed Description

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This study will evaluate the safety and the pharmacokinetics of ASC09F tablets in healthy volunteers. Subjects will receive 7 days multiple oral doses of ASC09F tablets.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASC09F

ASC09F one tablet at a time, once per day, up to 7 days.

Group Type EXPERIMENTAL

ASC09F

Intervention Type DRUG

ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.

Interventions

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ASC09F

ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 1\. Age 18-45 (including boundary value), half men and half women. 2. Male weight ≥ 50kg, female weight ≥ 45kg;BMI ranges from 19 to 30kg/m2 (boundary value included).

3\. According to the medical history, physical examination, vital signs, laboratory examination and 12 lead electrocardiogram (ECG) examination, the general health condition is good, and there is no clinically significant abnormality in each index.

4\. Unplanned pregnancy within half a year and willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration.

5\. The pregnancy test of female subjects during the screening period is negative.

6\. Those who voluntarily sign the informed consent.

Exclusion Criteria

* 1\. Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (HCV Ab), HIV antibody (HIV Ab) and syphilis antibody were tested positive.

2\. People who have taken special diet (including carambola, dragon fruit, mango, grapefruit, orange, etc.) or drunk alcohol, or had strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion within 2 weeks before taking the study drug.

3\. Heavy smokers (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine;Smoking daily ≥ 5 sticks) and no smoking or alcohol prohibition during the study period.

4\. Ingesting chocolate, any food or drink containing caffeine or xanthine in the 24 hours prior to taking the study drug.

5\. Patients who had donated blood or lost blood of more than 400ml within 3 months before taking the study drug.

6\. Those who have participated in other clinical trials and received study drug treatment within 3 months before taking study drug.

7\. Alcoholic or nonalcoholic fatty liver disease. 8. In addition to the above, the researchers judge that the participants are not suitable to participate in this clinical trial.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes