Study to Evaluate the Effect of Food on the Pharmacokinetics of ASC41 in Healthy Volunteers

NCT ID: NCT04692025

Last Updated: 2024-09-27

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

2020-12-27

Study Completion Date

2021-01-21

Brief Summary

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This study is to evaluate the effect of food on the pharmacokinetics of a single dose of ASC41 tablet in healthy volunteers, comparing fasting and postprandial pharmacokinetic parameters of Tmax, Cmax, AUC0-t, AUC0-∞.

Detailed Description

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Conditions

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Healthy NAFLD Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

ASC41 one tablet, on Day 1 before meal;ASC41 one tablet, on Day 15 after meal.

Group Type EXPERIMENTAL

ASC41 tablet

Intervention Type DRUG

Oral tablet

Group 2

ASC41 one tablet, on Day 1 after meal;ASC41 one tablet, on Day 15 before meal.

Group Type EXPERIMENTAL

ASC41 tablet

Intervention Type DRUG

Oral tablet

Interventions

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ASC41 tablet

Oral tablet

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 19kg/m2 ≤ BMI \<40kg/m2.

Exclusion Criteria

* A history of thyroid disease.
* History of, or current liver disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hunan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Gannex Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hunan provincial people's hospital

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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ASC41-103

Identifier Type: -

Identifier Source: org_study_id

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