Drug Interaction Study of Olmesartan in Healthy Chinese Volunteers

NCT01907373 | Completed Phase 4 DMC

• 1 other identifier: 200704
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension and hyperuricaemia are widespread conditions. There is significant overlap between the two conditions. Serum uric acid (SUA) is currently recognized as a risk factor for cardiovascular disease. Thus, at some point in their therapy, hypertensive patients with hyperuricaemia are likely to require concurrent treatment with anti-hypertensive and hypouricaemic agents. For this reason, it is important to determine whether there are any pharmacokinetic interactions resulting from the concomitant administration of such agents.Olmesartan is an angiotensin II receptor antagonist and effective and well tolerated in the treatment of arterial hypertension. Probenecid is a well-established hypouricaemic agent for the treatment of hyperuricaemia and gout.The goal of this study was to examine the impact of coadministration of probenecid on the pharmacokinetic parameters and tolerability of olmesartan in healthy volunteers.

Conditions

Drug Interaction of Olmesartan in Healthy Chinese Volunteers

Keywords

olmesartan; probenecid; pharmacokinetics; tolerability

Outcome Measures

Primary Outcomes (1)

• pharmacokinetic parameters

  pharmacokinetic parameters:AUC0-48, AUC0→∞ and Css-av , tmax, t1/2, Css-max, and Css-min

  48 hours after last administration of olmesartan medoxomil

Secondary Outcomes (1)

• vital signs

  at baseline (0) and at 1, 2, 3, 6, 12, 36, and 48 hours after last dosage of olmesartan medoxomil administration

Other Outcomes (2)

• Laboratory tests

  at baseline and after completion of the study during 48 hours

• electrocardiography

  at baseline and after completion of the study during 48 hours

Study Arms (2)

olmesartan medoxomil, PK of olmesartan

ACTIVE COMPARATOR

drug: olmesartan medoxomil; dosage form: oral tablet; dosage: 20mg/time; frequency: once a day; duration: 4 days

Drug: olmesartan medoxomil

olmesartan medoxomil+probenecid, PK of olmesartan

EXPERIMENTAL

drug1: olmesartan medoxomil; dosage form: oral tablet; dosage: 20mg/time; frequency: once a day; duration: 4 days; drug2: probenecid; dosage form: oral tablet; dosage: 500mg/time; frequency: 2 times/day; duration: 1 day

Drug: olmesartan medoxomil+probenecid

Interventions

olmesartan medoxomil DRUG

Also known as: BENICAR, CS-866

olmesartan medoxomil, PK of olmesartan

olmesartan medoxomil+probenecid DRUG

olmesartan medoxomil+probenecid, PK of olmesartan

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• written informed consent obtained,
• age 18 to 40 years and a body mass index between 19 and 25 kg/m2;
• negative test results for HIV and hepatitis В and C non-smoking status and
• an unremarkable clinical history

You may not qualify if:

• has history or evidence of a renal, gastrointestinal, hepatic, or hematologic abnormality or
• any acute or chronic disease, or
• an allergy to any drugs

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Center of New Drug Clinical Trial, Hunan Provincial Tumor Hospital (The Affiliated Tumor Hospital of Xiangya Medical School of Central South University)

Changsha, Hunan, 410006, China

Location

Related Publications (1)

• Li KY, Qiu Y, Jiang Y, Luo CH, Lin XP, Wang J, Yang N. Effect of probenecid on pharmacokinetics and tolerability of olmesartan in healthy chinese volunteers. Curr Ther Res Clin Exp. 2014 Jan 9;76:7-10. doi: 10.1016/j.curtheres.2013.11.004. eCollection 2014 Dec.

  PMID: 25067982 DERIVED

MeSH Terms

Interventions

Olmesartan Medoxomil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Kunyan Li, phD

  Center of New Drug Clinical Trial, Hunan Provincial Tumor Hospital (The Affiliated Tumor Hospital of Xiangya Medical School of Central South University)

  PRINCIPAL INVESTIGATOR

• Nong Yang, MS

  Center of New Drug Clinical Trial, Hunan Provincial Tumor Hospital (The Affiliated Tumor Hospital of Xiangya Medical School of Central South University)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center of New Drug Clinical Trial, Hunan Provincial Tumor Hospital (The Affiliated Tumor Hospital of Xiangya Medical School of Central South University)

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 25, 2013
• Study Start: August 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 25, 2013

Record last verified: 2013-07

Locations

CN (1)