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Nurigra Chewable Tablet in Healthy Adult Male Volunteers

NCT ID: NCT01651858

Last Updated: 2012-07-27

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nurigra Chewable tablet

Group Type EXPERIMENTAL

Nurigra Chewable tablet

Intervention Type DRUG

1 tablet of 100mg, once a day

Viagra

Group Type ACTIVE_COMPARATOR

Nurigra Chewable tablet

Intervention Type DRUG

1 tablet of 100mg, once a day

Interventions

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Nurigra Chewable tablet

1 tablet of 100mg, once a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy and male subjects aged 20 to 45 years
* A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently)
* A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints.

Exclusion Criteria

* A subject with sign or symptoms or previously diagnosed disease of liver
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW_SDF001

Identifier Type: -

Identifier Source: org_study_id