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 Co., Ltd.

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Conditions

Healthy Males

Interventions

Pelubiprofen IR (Pelubiprofen 30mg) TIDDRUG

Pelubiprofen SR (Pelubiprofen 45 mg) BIDDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

(Part1) Cmax,ss of Pelubiprofen IR (Pelubiprofen 30mg)

Time frame: 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)

Time frame: 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)

Time frame: 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)

(Part2) Cmax of Pelubiprofen IR (Pelubiprofen 30mg)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Data from ClinicalTrials.gov

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