A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Olmesartan Medoxomil 40 mg Film-coated Tablets and Reference Product in Healthy Thai Volunteers under Fasting Conditions

• Register: TCTR
• Last refreshed on: 29 April 2024
• Main ID: TCTR20170714002
• Date of registration: 14/07/2017
• Prospective Registration: Yes
• Primary sponsor: International Bio Service
• Public title: A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Olmesartan Medoxomil 40 mg Film-coated Tablets and Reference Product in Healthy Thai Volunteers under Fasting Conditions
• Scientific title: A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Olmesartan Medoxomil 40 mg Film-coated Tablets and Reference Product in Healthy Thai Volunteers under Fasting Conditions
• Date of first enrolment: 02/10/2017
• Target sample size: 32
• Recruitment status: Pending (Not yet recruiting)
• URL: https://www.thaiclinicaltrials.org/show/TCTR20170714002
• Study type: Interventional
• Study design: Randomized
• Phase: Phase 1

Countries of recruitment

Thailand

Contacts

• Name: Porranee Puranajoti
• Affiliation: International Bio Service

• Name: Porranee Puranajoti
• Affiliation: International Bio Service

Key inclusion & exclusion criteria

Inclusion criteria: 1.Healthy Thai male/female subjects between the ages of 18 to 55 years
2.Body mass index between 18.0 to 25.0 kg/m2
3.Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening
4.Non-pregnant woman (negative pregnancy test) and not currently breast feeding
5.Female subjects abstain from either hormonal methods of contraception (including oral or transdermal contraceptives, injectable progesterone, progestin subdermal implants, progesterone-releasing IUDs, postcoital contraceptive methods) or hormone replacement therapy for at least 28 days prior to admission in Period 1. Injectable contraceptives e.g. Depo-Provera® will be discontinued at least 6 months prior to admission in Period 1. Subjects agree to use acceptable non-hormonal contraceptive methods such as condom, diaphragm, foams, jellies, or abstinence for at least 14 days prior to admission in Period 1 until 14 days after the end of study. Female subjects of non-childbearing potential must meet at least one of the following criteria prior to admission in Period 1:
- Postmenopausal for at least 1 year or
- Surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) at least 6 months
6.Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after admission in Period 1 until 14 days after the end of study
7.Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study
Exclusion criteria: 1.History of allergic reaction or hypersensitivity to olmesartan medoxomil or any of the other excipients of this product
2.History or evidence of clinically significant renal, hepatic, gastrointestinal, hematological, endocrine, pulmonary or respiratory, cardiovascular, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness
3.History or evidence of hypotension or syncope
4.History or evidence of biliary obstruction
5.History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
6.History of problems with swallowing tablet
7.History of sensitivity to heparin or heparin-induced thrombocytopenia
8.Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy
9.History of preceding diarrhea within 24 hrs prior to admission in each period
10.History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine)
11.Have sitting systolic blood pressure of less than 90 mmHg or more than 139 mmHg and diastolic blood pressure of less than 60 mmHg or more than 89 mmHg on screening day and the day of admission. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 mins each. The last measurement value should be used to determine the subject’s eligibility
12.12-lead ECG demonstrating QTc >450 msec, a QRS interval >120 msec or with an abnormality considered clinically significant at screening. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject’s eligibility.
13.Investigation with blood sample shows positive test for HBsAg
14.Investigation with blood sample shows level of potassium less than 3.4 or more than 4.5 mmol/L at screening laboratory test
15.Investigation with blood sample shows level of creatinine less than 0.51 or more than 0.95 mg/dL for female and less than 0.67 or more than 1.17 mg/dL for male at screening laboratory test.
16.Investigation with blood sample shows level of creatinine phosphokinase (CPK) less than 26 or more than 192 U/L for female and less than 39 or more than 308 U/L for male at screening laboratory test.
17.Abnormal liver function, ≥ 1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test
18.Have renal creatinine clearance (CrCl) ≤60 mL/min based on serum creatinine results at the screening laboratory test
19.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
20.History or evidence of alcoholism, regular alcohol consumption or alcohol-containing products and cannot abstain for at least 7 days prior to admission and continued until last sample collection in each study period
21.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 7 days prior to admission and

Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Experimental Drug,Active Comparator Drug

Olmesartan,Olmetec

Olmesartan,Olmesartan

Primary Outcome(s)

Pharmacokinetic evaluation 0-48 hr drug concentration

Secondary Outcome(s)

Adverse events 0-48 hr Record of adverse events

Source(s) of Monetary Support

International Bio Service

Ethics review

Status: Submitted, approved
Approval date:
Contact:

Institute for the Development of Human Research Protections (IHRP)

[phone] Ext.

Results

• Date Completed: 25/12/2017