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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01870102
Enrollment
Unknown
Registered
2013-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Males

Brief summary

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

Interventions

DRUGPelubiprofen IR (Pelubiprofen 30mg) TID
DRUGPelubiprofen SR (Pelubiprofen 45 mg) BID

Sponsors

Daewon Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026