Study to compare pharmacokinetics of sildenafil chewable tablet with those of sildenafil film-coated tablet

A Randomized, Opne-label, Single dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess the Pharmacokinetic Charateristics of Sildenafil citrate Chewable Tablets Compared with Sildenafil citrate Film-coated Tablets under Fasted Conditions in Healthy Male Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000419

Enrollment

Registered

2012-04-24

Start date

2012-03-15

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 : Reference drug product: single oral dosing of 1 tablet of VIAGRA (sidenafil citrate 100 mg) in fasting condition Test drug product: single oral dosing of 1 chewable tablet of sidenafil citrate

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male volunteers between the ages of 20 and 55 years at screening 2. Subjects with a body weight within ± 20% of their ideal weight and over 55kg 3. Subjects have to be able to read, hear, and understand the detail of the study, and should decide to participate in the study volntarily and follow the study directions and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. History of hypersentivity to sildenafil citrate 2. Administration of organic nitrates 3. Subject who has retinitis pigmentosa 4. Current use of other PDE5 inhibitors such as VIAGRA, CIALIS, LEVITRA,ZYDENA, MVIX, and so on 5. Visual field loss due to non-arterial anterial ischemic optic neuropathy 6. Subjects with systolic blood pressure = 100 mmHg or = 150 mmHg, or diastolic blood pressure = 50 mmHg or = 145 mmHg, or with pulse rate 100 bpm 7. Subjects with AST or ALT count, the upper limit of reference range in excess of 1.25 times, or total bilirubin, the upper limit of reference range in excess of 1. 5 times 8. Presence or history of cardiovascular, pulmonary, renal, endocrine, hematologic, gastrointestinal, central nervous system, psychiatric, or malignant diseases 9. heavy drinker (more than 21 units/week) or heavy smoker (more than 20 cigarettes/day) 10. Use of any prescription drug, herbal medications within 14 days, or any over-the-counter medication within 7 days prior to scheduled study drug administration 11. Use of any other investigational drugs within 3 months prior to scheduled study drug administration 12. Donation of whole blood within 2 months or any blood products within 1 month, prior to scheduled study drug administration 13. Use of drugs which are P450 inducers or inhibitors (e.g. Phenobarbital) within 1 month prior to scheduled study drug administration 14. Current or previous abuse of drugs or alcohol

Design outcomes

Primary

Measure	Time frame
Cmax of sildenafil;AUC of sildenafil	—

Secondary

Measure	Time frame
tmax of sildenafil;Half-life of sildenafil;Cmax of UK-103320;AUC of UK-103320;tmax of UK-103320;Half-life of UK-103320	—

Countries

Korea, Republic of

Contacts

Public ContactJAEWOO KIM

Chungnam National University Hospital

Outcome results