Nurigra Chewable Tablet in Healthy Adult Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651858

Enrollment

Registered

2012-07-27

Start date

2012-02-29

Completion date

2012-03-31

Last updated

2012-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGNurigra Chewable tablet

1 tablet of 100mg, once a day

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026