NCT01651858

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
Last Updated

July 27, 2012

Status Verified

July 1, 2012

First QC Date

July 25, 2012

Last Update Submit

July 25, 2012

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • to Assess Pharmacokinetics

    AUC and Cmax in plasma

    24h after drug administration

Secondary Outcomes (1)

  • to Assess Safety

    24h after administration

Study Arms (2)

Nurigra Chewable tablet

EXPERIMENTAL
Drug: Nurigra Chewable tablet

Viagra

ACTIVE COMPARATOR
Drug: Nurigra Chewable tablet

Interventions

Nurigra Chewable tabletDRUG

1 tablet of 100mg, once a day

Nurigra Chewable tabletViagra

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • A subject with sign or symptoms or previously diagnosed disease of liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2012

First Posted

July 27, 2012

Study Start

February 1, 2012

Study Completion

March 1, 2012

Last Updated

July 27, 2012

Record last verified: 2012-07