Condition category
Not Applicable
Date applied
06/11/2012
Date assigned
08/11/2012
Last edited
15/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
This study tests the effect of two drugs, Olmetec Plus and Olmesartan in healthy Korean subjects.

Who can participate?
Healthy Korean volunteers, aged between 19 and 55 years.

What does the study involve?
Participants will be randomly allocated to one of two groups: A or B. During the first period, participants from group A will receive a reference drug (Olmetec Plus® ) while participants from group B will receive a test drug (Oldesar Plus). After one week, the order will be reversed.

What are the possible benefits and risks of participating?
There is no direct benefit from participation in the study. Information learned from the study may help other people in the future. Participants may experience side effects related to the study drug, but this will be monitored carefully for any negative effects. Participants may experience discomfort during blood sampling, include faintness, swelling or bruising at the site from where blood is drawn.

Where is the study run from?
Clinical Trial Center, Seoul, Korea

When is study starting and how long is it expected to run for?
The study started in June 2010 and ran until 2011.

Who is funding the study?
Pacific Pharma Corporation, Seoul, Korea

Who is the main contact?
Dr. Min-Gul Kim
mgkim@jbctc.org

Trial website

Contact information

Type

Scientific

Primary contact

Prof Min-Gul Kim

ORCID ID

Contact details

20
Geonji-ro
Deokjin-gu
Jeonju
561-172
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

BIBE2010-23

Study information

Scientific title

Pharmacokinetic properties and bioequivalence of olmesartan medoxomil versus ydrochlorothiazide in Korean subjects

Acronym

Study hypothesis

The present study aims at comparing the pharmacokinetics of the original formulation of Olmesartan medoxomil / Hydrochlorothiazide and a same generic product. This is necessary to demonstrate bioequivalence to regulatory authorities.

Ethics approval

Chonbuk National University Hospital Institutional Review Board, Jeonju, Republic of Korea, 28 June 2010, ref: CBBEIRB10-06-07

Study design

Open label randomised 2-treatment 2-period 2-sequence crossover design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Healthy Subjects

Intervention

To demonstrate the bioequivalence of a generic product containing phenazopyridine (one tablet x 100 mg) as test product Uropyrine® with the original formulation of phenazopyridine (one tablet x 100 mg) as reference product Pyridium®.
Both drugs will be administered orally in fasting state. All participants will be given each of the two drugs only once, in a cross-over design. The duration of washout period is 7 days.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measurement of the pharmacokinetic parameters:
1. Serum Cmax
2. AUC

Secondary outcome measures

Measurement of the pharmacokinetic parameters - Serum Tmax

Overall trial start date

08/07/2008

Overall trial end date

17/07/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy subjects aged 19 to 55
2. Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests
3. Informed consent signed by the subject
4. Not pregnant female subject

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Use of any drugs known to significantly induce or inhibit drug-metabolizing enzymes within 1 month prior to dosing
2. Use of prescription or nonprescription drugs within 10 days prior to the first dose of study medication
3. Subjects who are known or suspected not to comply with the study directives
4. Participating in a bioequivalence study or other clinical study within 3 month preceding the first dose of study medication
5. Pregnant or nursing females
6. Subject who are hypersensitive to study medication or other related compounds
7. History of sensitivity to thiazide diuretics or sulfonamides
8. Acute or Chronic renal failure (creatinine clearance < 30mL/min), anuric patient
9. Severe Hepatic failure
10. Biliary atresia, biliary cirrhosis
11. Hyponatremia, hypokalemia, hypercalcemia, hyperuricemia patient
12. Addison's disease patient
13. Galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption

Recruitment start date

08/07/2008

Recruitment end date

17/07/2008

Locations

Countries of recruitment

Korea, South

Trial participating centre

20, Geonji-ro
Jeonju
561-172
Korea, South

Sponsor information

Organisation

Pacific Pharma Corporation (Korea, South)

Sponsor details

710
Eonju-ro
Gangnam-Gu
Seoul
135-733
Korea
South

Sponsor type

Industry

Website

http://www.pacificpharm.co.kr/

Funders

Funder type

Industry

Funder name

Pacific Pharma Corporation (Korea, South)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24290413

Publication citations

  1. Results

    Jin C, Jeon JY, Im YJ, Jung JA, Kim Y, Park K, Choi Y, Chae SW, Kim MG, Pharmacokinetic properties and bioequivalence of olmesartan medoxomil/hydrochlorothiazide in healthy Korean male subjects., Int J Clin Pharmacol Ther, 2014, 52, 1, 64-72, doi: 10.5414/CP201991.

Additional files

Editorial Notes