Bioequivalence of olmesartan medoxomil versus hydrochlorothiazide in Korean subjects
| ISRCTN | ISRCTN18353234 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18353234 |
| Secondary identifying numbers | BIBE2010-23 |
- Submission date
- 06/11/2012
- Registration date
- 08/11/2012
- Last edited
- 15/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
20, Geonji-ro
Deokjin-gu
Jeonju
561-172
Korea, South
Study information
| Study design | Open label randomised 2-treatment 2-period 2-sequence crossover design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pharmacokinetic properties and bioequivalence of olmesartan medoxomil versus ydrochlorothiazide in Korean subjects |
| Study objectives | 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(s) | Chonbuk National University Hospital Institutional Review Board, Jeonju, Republic of Korea, 28 June 2010, ref: CBBEIRB10-06-07 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Measurement of the pharmacokinetic parameters: 1. Serum Cmax 2. AUC |
| Secondary outcome measures | Measurement of the pharmacokinetic parameters - Serum Tmax |
| Overall study start date | 08/07/2008 |
| Completion date | 17/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 08/07/2008 |
| Date of final enrolment | 17/07/2008 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
561-172
Korea, South
Sponsor information
Industry
710, Eonju-ro
Gangnam-Gu
Seoul
135-733
Korea, South
| Website | http://www.pacificpharm.co.kr/ |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2014 | Yes | No |
