Pharmacokinetic Drug Interaction Between Candesartan and Rosuvastatin

An Open-label, Multiple-dosing, Two-arm, One-sequence, Crossover Study to Evaluate the Safety and Pharmacokinetics After Oral Concurrent Administration of Candesartan 32 mg and Rosuvastatin 20 mg in Healthy Male Volunteers

The objective of this study is to compare pharmacokinetics after single oral administration of candesartan and rosuvastatin each separately versus coadministration of candesartan and rosuvastatin in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Rosuvastatin; Drug: Candesartan

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon
    • Jung-gu, Daejeon, Korea, Republic of, 301-721
      • Chungnam National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male volunteers af aged between 20 years to 45 years
• Have a weight above 55kg and Ideal body weight (IBW) between -20% and +20% inclusive
• Eligible subjects with acceptable medical history and physical examination

Exclusion Criteria:

- Have a known hypersensitivity or history of clinically significant hypersensitivity to drugs including the same class drugs with candesartan or rosuvastatin, or other drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment B	Drug: Rosuvastatin
Experimental: Treatment A	Drug: Candesartan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCτ,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
Cmax,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
AUCτ,ss of rosuvastatin	0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points
Cmax,ss of rosuvastatin	0(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tmax,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
CLss/F of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
Cmin,ss of candesartan	0h(pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 12 and 24 h	22 points
tmax,ss of rosuvastatin	0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points
CLss/F of rosuvastatin	0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points
Cmin,ss of rosuvastatin	0h(pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 9, 12 and 24 h	28 points

Collaborators and Investigators

• Sponsor: Alvogen Korea
• Investigators: Principal Investigator: JangHee Hong, PhD., Chungnam National University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 5, 2014
• Last Update Submitted That Met QC Criteria: March 4, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Rosuvastatin Calcium; Candesartan
• Other Study ID Numbers: DP-CTR208-I-01