Nurigra Chewable Tablet in Healthy Adult Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier:
NCT01651858
First received: July 25, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    AUC and Cmax in plasma


Secondary Outcome Measures:
  • to Assess Safety [ Time Frame: 24h after administration ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT01651858     History of Changes
Other Study ID Numbers: DW_SDF001
Study First Received: July 25, 2012
Last Updated: July 25, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

ClinicalTrials.gov processed this record on September 18, 2014