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Nurigra Chewable Tablet in Healthy Adult Male Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01651858
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : July 27, 2012
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

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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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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