Nurigra Chewable Tablet in Healthy Adult Male Volunteers

July 25, 2012 updated by: Daewoong Pharmaceutical Co. LTD.
The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurigra Chewable tablet
Drug: Nurigra Chewable tablet
1 tablet of 100mg, once a day
Active Comparator: Viagra
Drug: Nurigra Chewable tablet
1 tablet of 100mg, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to Assess Pharmacokinetics
Time Frame: 24h after drug administration
AUC and Cmax in plasma
24h after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to Assess Safety
Time Frame: 24h after administration
Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG
24h after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 25, 2012

First Submitted That Met QC Criteria

July 25, 2012

First Posted (Estimate)

July 27, 2012

Study Record Updates

Last Update Posted (Estimate)

July 27, 2012

Last Update Submitted That Met QC Criteria

July 25, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • DW_SDF001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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