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Nurigra Chewable Tablet in Healthy Adult Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01651858
First Posted: July 27, 2012
Last Update Posted: July 27, 2012
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.
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
  Purpose
The purpose of this study is to evaluate pharmacokinetics of sildenafil citrate in healthy male volunteers.

Condition Intervention Phase
Healthy Drug: Nurigra Chewable tablet Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Nurigra Chewable Tablet in Healthy Adult Male Volunteers

Further study details as provided by Daewoong Pharmaceutical Co. LTD.:

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


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


Estimated Enrollment: 52
Study Start Date: February 2012
Study Completion Date: March 2012
Arms Assigned Interventions
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

  Eligibility

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.


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01651858     History of Changes
Other Study ID Numbers: DW_SDF001
First Submitted: July 25, 2012
First Posted: July 27, 2012
Last Update Posted: July 27, 2012
Last Verified: July 2012