Phase 1 Study to Compare the Pharmacokinetic Characteristics and Food Effect of Pelubiprofen (30mg) Tablet IR and Pelubiprofen SR (as a Pelubiprofen 45 mg) Tablet in Healthy Subjects

Daewon Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy Males

Treatments: Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID; Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870102

DW330SR-1002(Ver1.1.)

Details and patient eligibility

About

Part 1 : A randomized, open Label, multiple doses, cross-over, phase I trial to investigate the pharmacokinetics of Pelubiprofen IR (Pelubiprofen 30mg) TID and Pelubiprofen SR (Pelubiprofen 45 mg) BID in healthy male volunteers Part 2 : A randomized, open label, single dose, cross-over, Phase I trial to investigate the food effect of Pelubiprofen SR (Pelubiprofen 45 mg) in healthy male volunteers

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult healthy males aged 20~40 years
• BMI valued over 19 kg/m2, below 27 kg/m2
• Subjects whose blood pressure ; systolic BP over 90mmHg below 140mmHg, diastolic BP over 60mmHg below 90mmHg, stable station pulse over 45 bpm below 100 bpm
• Subjects who agree with double protective contraception or able to certificate already sterilization operation 1 day before administration of Investigational new drugs within 14 days after completion
• Subjects who voluntarily agreed with written consent

Exclusion criteria

• Subjects with clinically significant disease or past medical history in hepatic, renal, GI tract, respiratory, musculoskeletal, endocrine, neuropsychiatry, blood tumor and cardiovascular system
• Subjects with GI tract disease (eg. Crohn's disease, peptic ulcer etc.) or surgery (except appendectomy and herniotomy) influence on administration Investigational new drugs
• Subjects with hypersensitivity reaction or clinically significant disease in drugs (Aspirin, NSAID anti-inflammatory agents and antibiotics) including Pelubiprofen and Food

Trial design

0 participants in 4 patient groups

Pelubiprofen IR (Pelubiprofen 30 mg)

Active Comparator group

Treatment:

Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID

Pelubiprofen SR (Pelubiprofen 45 mg)

Experimental group

Treatment:

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition

Other group

Treatment:

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Pelubiprofen SR (Pelubiprofen 45 mg) fed condition

Other group

Treatment:

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID