Safety and Pharmacokinetic Comparison of Sildenafil ODF and FCT Formulations in Healthy Korean Volunteers

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study investigates safety and pharmacokinetic comparison of Seoul Pharma's orally disintegrating film (ODF) formulation of sildenafil (test formulation) and Pfizer's "Viagra® (sildenafil)" Film Coated Tablet (FCT) formulation (reference formulation) in healthy volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seoul Pharma Co., Ltd.
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Eligible subjects were healthy male volunteers between the ages of 20 and 50 years and within 20% of their ideal body weight, and

• With no congenital abnormality or chronic disease.

Exclusion Criteria:

Key exclusion criteria included:

• history of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic, or hemorrhagic disease;

• anatomical abnormality of penis or factors that cause priapism (e.g., sicklemia, multiple myeloma, leukemia);

• clinically significant findings on routine laboratory (serology, hematology, serum chemistry, and urinalysis), ECG or color blindness tests [8, 16];

• history of hypersensitivity reaction to PDE5 inhibitor including sildenafil;

• use of prescription drugs within 14 days before the study that had the potential to interact with the study medication; and

• use of any substance that could induce or inhibit cytochrome P450 3A4 synthesis (eg, St. John's wort, other herbal medications).