Pharmacokinetics of Imrecoxib in Subjects With Hepatic Insufficiency

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-07-31

Brief Summary

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This clinical research study will assess pharmacokinetics and the safety of Imrecoxib in patients with impaired hepatic function as compared to healthy volunteers.

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Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients with im paired hepatic function

One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.

Group Type EXPERIMENTAL

Imrecoxib

Intervention Type DRUG

Healthy Volunteers

One dose of Imrecoxib followed by 5 days' pharmacokinetic sample collection.

Group Type EXPERIMENTAL

Imrecoxib

Intervention Type DRUG

Interventions

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Imrecoxib

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All subjects:

* Between the ages of 18 to 70 years, with BMI 18\~ 29kg/m2.
* In good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory test values(except for values related to hepatic insufficiency).

Hepatic impaired subjects:

* Hepatocirrhosis subjects verified by B-mode ultrasonography,CT ,MRI or Biopsy.
* A Child-Pugh Classification score clinically determined as Class B.

Exclusion Criteria

All subjects:

* History of hypersensitivity to Imrecoxib or its components.

Subjects diagnosed with tumor.

* History of or current clinically important systemic illnesses, including but not limited to cardiovascular, pulmonary, renal, hematological, gastrointestinal, endocrinological, immunological, dermatological, or psychiatric diseases.
* Have used any drugs or substances (including herbal supplements) known to inhibit or induce cytochrome P450 enzymes including cytochrome P450 3A4, cytochrome P450 2C8 and cytochrome P450 2C9 within 28 days prior to the first dose and throughout the study.
* Have taken other investigational drugs or participated in any clinical trial within 90 days prior to first dose of study drug in this study.

Hepatic impaired subjects:

* Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes