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A randomized, Open-Label, Single dose, Crossover Study to Evaluate the Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

A randomized, Open-Label, Single dose, Crossover Study to Evaluate the Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CRIS
Registry ID
KCT0000319
Enrollment
54
Registered
2012-01-11
Start date
2011-12-09
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Drug : Test group: HIP0908 100mg Reference group: Viagra 100mg Single dose, cross-over

Sponsors

Hanmi Pharm
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1)Age between 20 and 45 2)Weight: over 55kg and 18.5<BMI<25.0 3)Have to give their consent to participating clinical trial by oneself

Exclusion criteria

Exclusion criteria: Has a medical history of hypersensitivity to drug including PDE5 inhibitor and QTc>430ms or uncontrolled arrhythmia

Design outcomes

Primary

MeasureTime frame
AUC of Sildenafil;Cmax of Sildenafil—

Secondary

MeasureTime frame
AUC of N-desmethylsildenafil;Cmax of N-desmethylsildenafil—

Countries

Korea, Republic of

Contacts

Public ContactMini Jang

Hanmi Pharm

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026