Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis

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

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-01-31

Brief Summary

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For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

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Detailed Description

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This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis (accompanied by ascites).

Trial Design:

1. Open, single-center, multi-dose pharmacokinetics study
2. Study population:

Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
3. Dosage and mode of administration of investigational product:

Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.
4. Study duration:

Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day

Conditions

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Hepatic Cirrhosis Ascites

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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Tolvaptan 15mg tablet

Group Type EXPERIMENTAL

tolvaptan

Intervention Type DRUG

Drug: tolvaptan

tablet, 15mg, Qd, for 7 days.

Interventions

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tolvaptan

Drug: tolvaptan

tablet, 15mg, Qd, for 7 days.

Intervention Type DRUG

Other Intervention Names

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SAMSCA

Eligibility Criteria

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Inclusion Criteria

1. Hepatic Cirrhosis with ascites or lower extremities edema
2. Hospitalized patients
3. 18 years old\~75 years old
4. Inform Consent Form Signed

Exclusion Criteria

1. Patients with any of the following diseases, complications or symptoms:

* Hepatic encephalopathy (coma degree classification note 1 Grade 2 or above);
* Malignant ascites;
* Spontaneous bacterial peritonitis;
* Likely to have gastrointestinal bleeding during the study period;
* Heart failure (NYHA Note 2 Class Ⅲ andⅣ);
* Anuria (daily urine output below 100mL);
* Dysuria induced by urinary tract stenosis, calculus, or tumor.
2. Patients with any of the following history:

* With gastrointestinal bleeding within 10 days prior to screening;
* With cerebrovascular accident within 1 month prior to screening;
* With gout attack within 1 month prior to screening;
* With allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.).
3. Patients whose systolic blood pressure is below 90mmHg during screening;
4. Patients with abnormal values in the following lab examination indicators:

Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+\>145mmol/L(or higher than the upper limit of normal range), serum K+\> 5.5 mmol/L, uric acid\>476µmol/L, child-Pugh score\>10
5. Patients ineligible for oral medication
6. Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
7. Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
8. Patients having participated in clinical trials of other drugs within 1 month prior to screening;
9. Patients used to participate in clinical trials of Tolvaptan and take the said drug;
10. Patients determined by the investigator as illegible for the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No