Nurigra Chewable Tablet in Healthy Adult Male Volunteers | NCT01651858

Studies
Nurigra Chewable Tablet in Healthy Adult Male Volunteers

NCT01651858

Sponsor

Daewoong Pharmaceutical Co. LTD.

Status

Completed

Last Update Posted

Jul 27, 2012Estimated

Enrollment

52Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

Nurigra Chewable tablet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Not provided

Completion Date

Mar 2012Actual

First Submitted Date

Jul 25, 2012

First Submission Date that Met QC Criteria

Jul 25, 2012

First Posted Date

Jul 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2012

Last Update Posted Date

Jul 27, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nurigra Chewable tablet	Experimental		Drug: Nurigra Chewable tablet
Viagra	Active Comparator		Drug: Nurigra Chewable tablet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nurigra Chewable tablet	Drug	1 tablet of 100mg, once a day	Nurigra Chewable tablet Viagra

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to Assess Pharmacokinetics	AUC and Cmax in plasma	24h after drug administration

Secondary Outcomes

Measure	Description	Time Frame
to Assess Safety	Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG	24h after administration

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided