Skip to main content
OpenTrials
Completed

NCT Number: NCT01651858

Nurigra Chewable Tablet in Healthy Adult Male Volunteers

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurigra Chewable tablet

Drug

1 tablet of 100mg, once a day

Primary outcomes

  1. to Assess Pharmacokinetics

    Time frame: 24h after drug administration

    AUC and Cmax in plasma

Secondary outcomes

  1. to Assess Safety

    Time frame: 24h after administration

    Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Important dates

Study start
2012
Study completion
2012
First posted
Jul 27, 2012
Registry last updated
Jul 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.