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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Open Label, Cross-over, Phase 1 Trial to Investigate the Pharmacokinetics in Multi-dose and the Food Effect in Single-dose of Pelubiprofen IR and Pelubiprofen SR in Healthy Male Volunteers

Conditions
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Healthy Males

Intervention / Treatment
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* Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID
* Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pelubiprofen IR (Pelubiprofen 30 mg)<br> | Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID<br> <br> |
| Experimental: Pelubiprofen SR (Pelubiprofen 45 mg)<br> | Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID<br> <br> |
| Other: Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition<br> | Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID<br> <br> |
| Other: Pelubiprofen SR (Pelubiprofen 45 mg) fed condition<br> | Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part1) Cmax,ss of Pelubiprofen IR (Pelubiprofen 30mg) |  | 0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times) | 
| (Part1) Cmax,ss of Pelubiprofen SR (Pelubiprofen 45 mg) |  | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times) | 
| (Part1) Dose normalized AUCτ,ss of Pelubiprofen IR (Pelubiprofen 30mg) |  | 0(pre-dose), 0.25h, 0.5.h, 0.75h, 1h, 1.5h, 2h, 4h, 6h, 6.5h, 7h, 8h, 12h, 12.5h, 13h, 14h, 24h, 60h, 72h, 72.25h, 72.5h, 72.75h, 73h, 73.5h, 74h, 76h, 78h, 80h, 84h, 96h (total 30 times) | 
| (Part1) Dose normalized AUCτ,ss of Pelubiprofen SR (Pelubiprofen 45 mg) |  | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 12h, 13h, 14h, 16h, 24h, 60h, 72h, 72.5h, 73h, 73.5h, 74h, 74,5h. 75h. 75.5h, 76h, 77h, 78h, 80h, 84h, 96h (total 32 times) | 
| (Part2) Cmax of Pelubiprofen IR (Pelubiprofen 30mg) |  | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) | 
| (Part2) Cmax of Pelubiprofen SR (Pelubiprofen 45 mg) |  | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) | 
| (Part2) AUClast of Pelubiprofen IR (Pelubiprofen 30mg) |  | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) | 
| (Part2) AUClast of Pelubiprofen SR (Pelubiprofen 45 mg) |  | 0(pre-dose), 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 5h, 6h, 8h, 10h, 12h, 24h (15times each period, total 30 times) |