NCT01823900

A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers

Completed Phase 1 Last updated 9 April 2013

What this trial tests

Phase 1 trial testing Test formulation in Healthy in 58 participants. Completed in 1 March 2012.

Timeline

1 January 2012

Primary endpoint
1 February 2012

1 March 2012

Quick facts

Lead sponsor	Severance Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	58
Start date	1 January 2012
Primary completion	1 February 2012
Estimated completion	1 March 2012
Sites	1 location across South Korea

Drugs / interventions tested

• Test formulation
• Reference formulation

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Severance Hospital

Who can join

Adults 20 to 50, male only, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Profile of Pharmacokinetics
  Time frame: 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose
  Cmax, Area Under Curve (0 to last sampling time)

Sponsor's own description

This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects.
   Son H, Roh H, Lee D, Chang H, et al · · 2013 · cited 8× · PMID 23810276 · DOI 10.1016/j.clinthera.2013.05.016