Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.

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

Details

• Lead Sponsor: CERESPIR
• Treatments: Flurbiprofen

Criteria

Inclusion Criteria:

• Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.

Exclusion Criteria:

• Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.

• Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.

• Significant allergic conditions that require medical treatment

• Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.

• Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.