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
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 April 16, 2014