A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

Renal Impairment Clinical Trial

Official title:

A Clinical Trial to Compare and Evaluate the Pharmacokinetic Characteristics and the Safety of Fimasartan in Renal Impairment Patients and Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148368
• Other study ID #: A657-BR-CT-113
• Status: Completed
• Phase: Phase 1
• First received: June 21, 2010
• Last updated: January 6, 2012
• Start date: June 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2010
• Source: Boryung Pharmaceutical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of fimasartan in renal impairment patients and healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

<Renal impairment patient>

• age: 20-65 years

• eGFR: < 30ml/min/1.73m^2

• not on dialysis

• body weight: greater than 55kg

• written informed consent

<Healthy volunteer>

• age: 20-65 years

• body weight: greater than 55kg

• written informed consent

Exclusion Criteria:

• AST, ALT > 1.5 times of upper normal range

• positive drug or alcohol screening

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• fimasartan
single administration of fimasartan 120mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Boryung Pharmaceutical Co., Ltd	Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetic characteristic of fimasartan	AUC, Cmax, Tmax, T1/2, and CL/F of fimasartan	0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 32, 48h	Yes