Nurigra Chewable Tablet in Healthy Adult Male Volunteers

Daewoong Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Nurigra Chewable tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651858

DW_SDF001

Details and patient eligibility

About

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

Enrollment: 52 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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52 participants in 2 patient groups

Nurigra Chewable tablet

Experimental group

Treatment:

Drug: Nurigra Chewable tablet

Viagra

Active Comparator group

Treatment:

Drug: Nurigra Chewable tablet