Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DreamPharma
ClinicalTrials.gov Identifier:
NCT01429688
First received: August 29, 2011
Last updated: September 6, 2011
Last verified: September 2011

August 29, 2011
September 6, 2011
July 2011
August 2011   (final data collection date for primary outcome measure)
Composite of pharmacokinetics [ Time Frame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h ] [ Designated as safety issue: No ]
Cmax, ss, AUCτ
Same as current
Complete list of historical versions of study NCT01429688 on ClinicalTrials.gov Archive Site
Composite of pharmacokinetics [ Time Frame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h ] [ Designated as safety issue: No ]
tmax,ss, t1/2, Cav,ss, PTF, AI, Cmin,ss
Same as current
Not Provided
Not Provided
 
Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers
A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects

The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male volunteers.

The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days second.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Healthy
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
  • Anplag : 0007-1
  • Experimental: DP-R202
    Multiple oral administration for 3 days
    Intervention: Drug: Anplag
  • Active Comparator: Anplag
    Multiple oral administration for 3days
    Intervention: Drug: Anplag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01429688
DP-SACL-I-003
No
DreamPharma
DreamPharma
Not Provided
Principal Investigator: Jae Wook Ko, MD, PhD Samsung Medical Center
DreamPharma
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP