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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

Sponsor
Daewon Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01870102
Collaborator
(none)
4
Arms

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID
  • Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID
 Phase 1

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
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
Actual Primary Completion Date :
Aug 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Pelubiprofen IR (Pelubiprofen 30 mg)

Drug: Pelubiprofen IR (Pelubiprofen 30mg) TID
Experimental: Pelubiprofen SR (Pelubiprofen 45 mg)

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID
Other: Pelubiprofen SR (Pelubiprofen 45 mg) fasting condition

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID
Other: Pelubiprofen SR (Pelubiprofen 45 mg) fed condition

Drug: Pelubiprofen SR (Pelubiprofen 45 mg) BID

Outcome Measures

Primary Outcome Measures

  1. (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)]

  2. (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)]

  3. (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)]

  4. (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)]

  5. (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)]

  6. (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)]

  7. (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)]

  8. (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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Daewon Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daewon Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01870102
Other Study ID Numbers:
  • DW330SR-1002(Ver1.1.)
First Posted:
Jun 5, 2013
Last Update Posted:
Jan 14, 2014
Last Verified:
Jan 1, 2014

Study Results

No Results Posted as of Jan 14, 2014