Pharmacokinetics of Sildenafil Orally Soluble Film

A randomized, open, single dose, 2-way crossover study in healthy male volunteers to evaluate the safety and the pharmacokinetics of Please orally soluble film 50 mg (Sildenafil) without water relative to VIAGRA® 50 mg (Sildenafil citrate) with water

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000734

Enrollment

Registered

2013-04-29

Start date

2012-08-16

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 drug: sildenafil OSF 50mg PO once Reference drug: Viagra® 50mg PO once

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Healthy male subjects between the ages of 20 and 55 years 2. Ideal Body Weight(IBW) of +-20%; and a total body weight >= 50 kg 3. An informed consent document signed and dated by the subject.

Exclusion criteria

Exclusion criteria: 1. Evidence or a history of clinically significant hepatic, pancreas, renal, neurological, pulmonary, endocrine, hematological, psychiatric, cardiovascular, eye, genitourinary disease 2. Any disease or history possibly affecting drug absorption (e.g. chohn's disease, gastrectomy). 3. Any condition possibly affecting drug absorption (stomatitis, glottitis) 4. sildenafil-associated allergy history 5. systolic blood pressure (SBP) = 150 mmHg or =100 mmHg or diastolic blood pressure (DBP) = 95 mmHg or = 65 mmHg 6. received any prescription medication or herbal medicines within 3 weeks or any over-the-counter medication within 10 days before the study

Design outcomes

Primary

Measure	Time frame
Cmax;AUClast	—

Secondary

Measure	Time frame
AUCinf	—

Countries

Korea, Republic of

Contacts

Public ContactMin-Gul Kim

Chonbuk National University Hospital

mgkim@jbnu.ac.kr+82-63-250-1487

Outcome results