A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Alfuzosin XR 10 mg tablets relative to Xatral® XL 10 mg tablets in healthy Thai male volunteers under fed conditio

Phase 1

• Conditions: Bioequivalence study in healthy male volunteers; Bioequivalence; Alfuzosin XR 10 mg tablets; Alfuzosin

• Registration Number: TCTR20180605003
• Lead Sponsor: Bio-innova and Synchron.Co.,Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-05
• Study Completion: 2018-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

1.Healthy Thai male subjects are between 18 to 55 years of age.
2.The Body Mass Index (BMI) ranges from 18 to 25 kg/m2.
3.Healthy, no history of evidence of chronic disease or severe disorder.
4.No history of usually smoking (more than 10 cigarettes per day) or use cotinine containing product but can stop smoking at least 6 months before the study drug administration and until the completion of the study.
5.No history of alcoholism (more than 2 years).

Exclusion Criteria

1.History or evidence of allergy or hypersensitivity to Alfuzosin or alpha-blockers or any related drugs or any of the excipients of this product.
2.Subject with B.P. is Systolic B.P < 90, ≥140 mm/Hg, Diastolic B.P < 60, ≥90 mm/Hg or pulse rate > 100 beats per minute.
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 or C virus or HIV.
7.Have more than one abnormal EKG, which is considered as clinically significant.*
8.History or evidence of heart, renal, hepatic disease, pulmonary obstructive disease, bronchial asthma, hypertension, or glaucoma.
9.History or evidence of gastrointestinal disorder likely to influence drug absorption or previous GI surgery other than appendectomy.
10.Any major illness in the past 3 months or any significant ongoing chronic medical illness.
11.History of psychiatric disorder.
12.History of regular alcohol consumption 14 drinks/week (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.
13.History of usually smoking (more than 10 cigarettes per day), if moderate smokers (less than 10 cigarettes per day) cannot stop at least 6 months before the study drug administration and until the completion of the study.
14.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.
15.Positive drug abused test in urine (Benzodiazepines, Marijuana (THC), Amphetamine, Cocaine and Opioids).
16.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 7 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.
17.History of difficulty in accessibility of veins in left or right arm.
18.Blood donation (one unit or 350 mL) within the past 3 months before the study.
19.Participation in any clinical study within the past 3 months before the study.
20.Subjects who are unwilling or unable to comply with the lifestyle guidelines described in this protocol.
(* Depend on decision of principal investigator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cmax, AUC0→t, AUC0→∞ 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 24, 36 and 48 hours Pharmacokinetic parameters

Secondary Outcome Measures

Name	Time	Method
Safety; Adverse events (abnormal blood pressure) 1.0, 2.0, 3.0, 4.0, 6.0, 8.0, 12.0, 24.0, 36.0 and 48.0 hours Safety monitoring