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

NCT01870102 | Completed Phase 1

• 1 other identifier: DW330SR-1002(Ver1.1.)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Healthy Males

Outcome Measures

Primary Outcomes (8)

• (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)

Study Arms (4)

Pelubiprofen IR (Pelubiprofen 30 mg)

ACTIVE COMPARATOR

Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID

Pelubiprofen SR (Pelubiprofen 45 mg)

EXPERIMENTAL

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition

OTHER

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Pelubiprofen SR (Pelubiprofen 45 mg) fed condition

OTHER

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Interventions

Pelubiprofen IR (Pelubiprofen 30mg) TID DRUG

Pelubiprofen IR (Pelubiprofen 30 mg)

Pelubiprofen SR (Pelubiprofen 45 mg) BID DRUG

Pelubiprofen SR (Pelubiprofen 45 mg); Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition; Pelubiprofen SR (Pelubiprofen 45 mg) fed condition

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

pelubiprofen; BID protein, human

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2013
• First Posted: June 5, 2013
• Primary Completion: August 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01