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Nurigra Chewable Tablet in Healthy Adult Male Volunteers

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ClinicalTrials.gov Identifier: NCT01651858
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Nurigra Chewable tablet Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Nurigra Chewable Tablet in Healthy Adult Male Volunteers
Study Start Date : February 2012
Actual Study Completion Date : March 2012

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



Primary Outcome Measures :
  1. to Assess Pharmacokinetics [ Time Frame: 24h after drug administration ]
    AUC and Cmax in plasma


Secondary Outcome Measures :
  1. to Assess Safety [ Time Frame: 24h after administration ]
    Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01651858     History of Changes
Other Study ID Numbers: DW_SDF001
First Posted: July 27, 2012    Key Record Dates
Last Update Posted: July 27, 2012
Last Verified: July 2012