Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers

NCT01823900 | Completed Phase 1

• 1 other identifier: DWJ1276
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Profile of Pharmacokinetics

  Cmax, Area Under Curve (0 to last sampling time)

  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

Secondary Outcomes (1)

• Profile of Pharmacokinetics

  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

Study Arms (1)

Test and reference formulations

EXPERIMENTAL

Test formulation and reference formulation given orally 7 days apart in a fasted state

Drug: Test formulation; Drug: Reference formulation

Interventions

Test formulation DRUG

Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg

Test and reference formulations

Reference formulation DRUG

Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet

Test and reference formulations

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease

You may not qualify if:

• History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease;
• Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests;
• Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication;
• Use of any substance that could induce or inhibit drug metabolism enzymes

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (1)

• Son H, Roh H, Lee D, Chang H, Kim J, Yun C, Park K. Pharmacokinetics of rosuvastatin/olmesartan fixed-dose combination: a single-dose, randomized, open-label, 2-period crossover study in healthy Korean subjects. Clin Ther. 2013 Jul;35(7):915-22. doi: 10.1016/j.clinthera.2013.05.016. Epub 2013 Jun 27.

  PMID: 23810276 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 24, 2013
• First Posted: April 4, 2013
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 11, 2013

Record last verified: 2013-04

Locations

KR (1)