Clinical Study to Investigate the Safety and Pharmacokinetics of SK3530 Tablet in Renal Impaired Male Patients

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

2009-11-30

Brief Summary

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This study is designed to investigate the effect of renal impairment on the safety and pharmacokinetics of SK3530 in subjects with renal impairment compared to healthy subjects.

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Detailed Description

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Conditions

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Renal Insufficiency Kidney Diseases Urologic Diseases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

Group Type EXPERIMENTAL

Mirodenafil

Intervention Type DRUG

50mg Single Oral Dose of

Patients with severe renal impairment

Group Type EXPERIMENTAL

Mirodenafil

Intervention Type DRUG

50mg Single Oral Dose of

Interventions

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Mirodenafil

50mg Single Oral Dose of

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult males aged 19 to 64 years at screening.
* Subjects with body weight ≥ 50 kg and within ±30% of the ideal body weight : Ideal body weight = (height \[cm\] - 100)x0.9.
* Subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol.

Exclusion Criteria

* Subjects with the test results of QTc \> 430 ms or non-sinus cardiac rhythm by ECG analysis.
* Subjects with hypotension or hypertension.
* Subjects deemed ineligible by investigator based on other reasons, including abnormal laboratory values or diseases.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes