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
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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24290413
Publication citations
-
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.