A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Tamsulosin Hydrochloride, 0.4 mg prolonged release tablets relative to Harnal OCAS® 0.4 mg tablets in healthy Thai male volunteers under fed conditio
- Conditions
- Bioequivalence studyTamsulosin
- Registration Number
- TCTR20181204003
- Lead Sponsor
- Bio-innova and Synchron.Co.,Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- Male
- Target Recruitment
- 44
1.Willingness to provide written informed consent prior to participate in the study.
2.Healthy male Thai subjects between 18 to 55 years of age (both inclusive).
3.The Body Mass Index (BMI) ranges from 18.5 to 30 kg/m2 (both inclusive).
4.Comprehensive of the nature and purpose of the study and compliance with the requirement of the entire protocol and allow investigators to draw 7 mL of blood for monitoring subjects’ safety after the completion of the study.
5.Negative breath alcohol test on screening day
6.Absence of significant diseases or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or surgery during the screening. Any abnormalities or deviations outside the normal ranges for any of clinical testing (laboratory tests, EKG, vital signs) can be repeated at the discretion of the investigator(s) and judged to be not clinically significant for study participation
7.For male volunteers, one of the following must apply in order to avoid impregnating a female partner, from the first study dose until 1 week post last dose:
•Abstinence
•Use of barrier method
1.History or evidence of allergy or hypersensitivity to Tamsulosin hydrochloride or any related drugs or any of the excipients of this product.
2.Subject with B.P. is Systolic B.P < 100, ≥140 mm/Hg, Diastolic B.P < 70, ≥90 mm/Hg or pulse rate > 100 beats per minute on screening day. For study periods, BP evaluation criteria for AE will be < 90, ≥140 mm/Hg, Diastolic B.P < 60, ≥90 mm/Hg.
3.Serum bilirubin greater than 1.5 times the upper limit of reference range (ULRR).*
4.Serum creatinine greater than 1.5 times the upper limit of reference range (ULRR).*
5.Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2 times the upper limit of reference range (ULRR).*
6.Positive of hepatitis B surface antigen or hepatitis C antibody or HIV antibody.
7.Positive of urine cotinine analysis test (Screening).
8.Have more than one abnormal EKG, which is considered as clinically significant. *
9.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, glaucoma.
10.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
11.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
12.History of psychiatric disorder.
13.History of regular alcohol consumption exceeding 14 drinks/week within the past 1 year (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) and cannot stop at least 2 days before the study drug administration and until the completion of the study.
14.History of smoking within the past three months and willing to refrain from smoking until the completion of the study.
15.High caffeine consumption (more than 5 cups of coffee or tea per day) and cannot stop at least 2 days before the study drug administration and until the completion of the study.
16.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids).
17.Receipt of any prescription drug therapy within 14 days or 5 half-lives (whichever longer) preceding the first dose of study medication or over-the-counter (OTC) drugs or herbal medicines/food supplement within 14 days or hormonal methods of contraception within 28 days (Depo-Provera® must be discontinued at least 6 months) prior to receiving the first dose of study medication. Inducers / inhibitors of CYP enzymes (e.g. pimozide, terfenadine, astemizole, cisapride, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir, rifampin, carbamazepine, phenytoin) are not allowed from 28 days before dosing in Period 1 until the completion of the study.
18.History of difficulty in accessibility of veins in left and right arm.
19.Blood donation (one unit or 450 mL) within the past 3 months before the study.
20.Participation in any clinical study within the past 3 months before the study.
21.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
22.Have had a tattoo or body piercing within 90 days prior to the first dose.
23.Presence of significant infection within 1 week prior to screening and check-in.*
(* Depend on decision of principal investigator and/or clinical inve
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cmax, AUC0-t and AUC0-inf 0,1, 2, 3, 4, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 10, 12, 14, 16, 24, 36, 48 and 72 hours Pharmacokinetic parameters
- Secondary Outcome Measures
Name Time Method Safety 2.0, 4.0, 5.0, 6.0, 8.0, 12.0, 24.0, 36.0, 48.0 and 72.0 hours Safety monitoring