Study to Evaluate the Effects of Food Ingestion on the Pharmacokinetics of CHF 5074 in Healthy Young Male Subjects

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the effects of a high-calorie high-fat meal on the extent and rate of absorption of CHF 5074 after single oral administration in young healthy male volunteers.

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

Details

• Lead Sponsor: CERESPIR

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.

• Subject has a body mass index between 18 and 30 kg/m^2, inclusive.

Exclusion Criteria:

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

• Abnormal result 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.