Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions

NCT06316336 | Not Yet Recruiting Phase 1

• 1 other identifier: BE24-005
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy subjects under fed conditions and To evaluate safety of test and reference formulations Study Design: An open label, randomized, two-treatment, two-period, two-sequence, multiple oral dose, crossover bioequivalence study in healthy Thai male volunteers under fed conditions with at least 7 days washout period between last dosing of Period 1 and first dosing of Period 2.

Conditions

Healthy Vollunteer

Keywords

Alfuzosin Hydrochloride; Bioequivalence study

Outcome Measures

Primary Outcomes (2)

• Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

  Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

  Through Day 6 and Day 7 post dose

• Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

  Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets

  Day 6 and Day 7 post dose

Study Arms (2)

Generic Alfuzosin Hydrochloride 10 mg

EXPERIMENTAL

Generic Alfuzosin Hydrochloride 10 mg (test drug)

Drug: Alfuzosin Hydrochloride 10 mg; Drug: Xatral® XL 10 mg

Xatral® XL 10 mg

ACTIVE COMPARATOR

Xatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg (reference drug))

Drug: Alfuzosin Hydrochloride 10 mg; Drug: Xatral® XL 10 mg

Interventions

Alfuzosin Hydrochloride 10 mg DRUG

Alfuzosin Hydrochloride 10 mg (test durg)

Generic Alfuzosin Hydrochloride 10 mg; Xatral® XL 10 mg

Xatral® XL 10 mg DRUG

Xatral® XL 10 mg (reference drug)

Also known as: Alfuzosin Hydrochloride 10 mg

Generic Alfuzosin Hydrochloride 10 mg; Xatral® XL 10 mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Thai male subjects between the ages of 18 to 55 years
• Body mass index between 18.5 to 30.0 kg/m2
• Normal laboratory values, including vital signs and physical examination, for all parameters in clinical laboratory tests at screening. Any abnormalities from the normal or reference range will be carefully considered clinically relevant by the physician as individual cases, documented in study files prior to enrolling the subject in this study.
• Male subjects who are willing or able to use effective contraceptive e.g. condom or abstinence after check-in in Period 1 until 7 days after the end of study in Period 2.
• Have voluntarily given written informed consent (signed and dated) by the subject prior to participating in this study

You may not qualify if:

• History of allergic reaction or hypersensitivity to alfuzosin or any of the other components of this product.
• History or evidence of clinically significant renal, hepatic, gastrointestinal (e.g. intestinal occlusion), hematological, endocrine (e.g. hyper-/hypothyroid), pulmonary or respiratory (e.g. allergic rhinitis, asthma), cardiovascular (e.g. hyper-/hypotension), psychiatric (e.g. depression), neurologic (e.g. convulsant), allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) or any significant ongoing chronic medical illness.
• Have high risk for coronavirus infection based on risk assessment questionnaire or diagnosed as confirmed case of COVID-19.
• History about administration of COVID-19 vaccine within 30 days prior to check-in in each Period.
• History or evidence of regular faintness, dizziness, headache or postural hypotension.
• History or evidence of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• History of problems with swallowing tablet or capsule.
• History of sensitivity to heparin or heparin-induced thrombocytopenia.
• Any condition possibly affecting drug absorption e.g. gastrectomy, enterectomy, gastritis or duodenal or gastric ulceration other than appendectomy.
• History of diarrhea or vomiting within 24 hours prior to check-in in each period.
• History or evidence of drug addict or investigation with urine sample shows a positive test for drug of abuse (morphine, marijuana or methamphetamine).
• 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 on the check-in day. If abnormal blood pressure detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility.
• Investigation of vital signs shows pulse rate less than 60 or more than 100 beats per minute on screening day and on the check-in day. If abnormal pulse rate detects, the measurement should be repeated two more times after take a rest for at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility.
• 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 will be repeated two more times and the average of the three QTc or QRS values will be used to determine the subject's eligibility.
• Investigation with blood sample shows positive test for HBsAg. 16.Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test.

Sponsors & Collaborators

• Pharma Nueva: lead

MeSH Terms

Interventions

alfuzosin

Study Officials

• Porranee Puranajoti

  International Bio service

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aksorn Jarupintusopon

CONTACT

0918744146; aksorn.riengsilchai@pharmanueva.com

Thanaporn Wongyai

CONTACT

024415211; thanaporn.won@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 18, 2024
• Study Start: June 10, 2024
• Primary Completion: June 22, 2024
• Study Completion: June 28, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share