Healthy VollunteerPhase 1BE24-005NCT06316336
Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions
A Phase 1 study testing Alfuzosin Hydrochloride 10 mg and Xatral® XL 10 mg in people with Healthy Vollunteer, run by Pharma Nueva.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Vollunteer
- What is being tested?
- Alfuzosin Hydrochloride 10 mg and Xatral® XL 10 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 10 Jun 2024to 28 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- 14.12-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 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.
- 15.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.
- 17.Have eGFR (CKD-EPI) < 30 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment.
- 18.History or evidence of habitual use of tobacco or nicotine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study.
- 19.History or evidence of alcoholism or harmful use of alcohol (less than 2 years) i.e., alcohol consumption of more than 14 standard drinks per week for men (A standard drink is defined as 360 mL of beer or 150 mL of wine or 45 mL of 40% distilled spirits, such as rum, whisky, brandy, etc.).
- 20.History or evidence of alcohol consumption or alcohol-containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study or alcohol breath test shows positive result. In case of alcohol breath test result represents the alcohol concentration range of 1 - 10 mg% BAC and the physician carefully considers that the value came from other reasons, not from the alcohol drinking behavior of subjects, the test will be repeated two times separately, not more than 10 minutes. The result of the last time should be used for subject's eligibility which must be 0 mg%BAC.
- 21.History or evidence of habitual consume of tea, coffee, xanthine or caffeine containing products and cannot abstain for at least 48 hours prior to check-in in Period 1 and continued for entire duration of the study.
- 22.Consume or drink juice of grapefruit or orange or pomelo or its supplement / containing products and cannot abstain for at least 7 days prior to check-in in Period 1 and continued for entire duration of the study.
- 23.Use of prescription or nonprescription drugs (e.g. nitrates, paracetamol, erythromycin, clarithromycin, ketoconazole, itraconazole, prazosin, urapidil or minoxidil etc.), herbal medications or supplements (e.g. St. John's wort), vitamins or mineral (e.g. iron) or dietary supplements within 14 days prior to check-in in Period 1 and continued for entire duration of the study.
- 24.Participated in other clinical trials within 90 days prior to check-in in Period 1 (except for the subjects who drop out or withdrawn from the previous study prior to Period 1 dosing) or still participates in the clinical trial or participates in other clinical trials during enrollment in this study.
- 25.Blood donation or blood loss ≥ 1 unit (1 unit is equal to 350-450 mL of blood) within 90 days prior to check-in in Period 1 or during enrollment.
- 26.Subjects with poor venous access or intolerant to venipuncture. 27.Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study.
- 28.Inability to communicate well (i.e. language problem, poor mental development, psychiatric illness or poor cerebral function) that may impair the ability to provide written informed consent or cooperate with clinical team.
- 29.Subjects who are employees of International Bio Service Co., Ltd., Pharma Nueva Co., Ltd. or Siam Pharmaceutical Co., Ltd.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Randomized, Multiple Dose, Two-way Crossover Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Reference Product (Xatral® XL 10 mg) in Healthy Thai Male Volunteers Under Fed Conditions
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.
Read the detailed description
Each subject will receive a single dose of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, as a test formulation (T) or a single dose of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg, as a reference formulation (R), with 240±2 mL of ambient temperature drinking water at 30 minutes after the start of standardized HFHC breakfast. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the tablet. This activity will be followed by a mouth check using a tongue depressor and a flashlight to assess the compliance of dosing. The formulations will be given in a crossover fashion as per the randomization schedule. The dosing processes will be conducted under normal light condition.
In each period, total of 21 blood samples will be collected from 21 sampling time points. Blood samples (6 mL each) will be collected as per the following schedule:
- Pre-dose blood sample collection (Day 1, Day 4, Day 5 and Day 6) Total of 4 pre-dose blood samples (6 mL each) will be collected from 4 pre-dose sampling time points on Day 1, Day 4, Day 5 and Day 6.
- Post-dose blood sample collection (Day 6 and Day 7) Total of 17 post-dose blood samples (6 mL each) will be collected from 17 post-dose sampling time points at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00 and 24.00 hours post-dose.
- Conditions
- Healthy Vollunteer
- Being tested
- Alfuzosin Hydrochloride 10 mg, Xatral® XL 10 mg
- Keywords
- Alfuzosin Hydrochloride, Bioequivalence study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin Hydrochloride 10 mgDrug
Alfuzosin Hydrochloride 10 mg (test durg)
Xatral® XL 10 mgDrug
Also called Alfuzosin Hydrochloride 10 mg
Xatral® XL 10 mg (reference drug)
| Study group | Role | What they receive |
|---|---|---|
| Generic Alfuzosin Hydrochloride 10 mg | Experimental | Generic Alfuzosin Hydrochloride 10 mg (test drug) Receives: 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)) Receives: Drug: Alfuzosin Hydrochloride 10 mg; Drug: Xatral® XL 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 6 and Day 7 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start10 Jun 2024 (estimated)
- Primary completion22 Jun 2024 (estimated)
- Study completion28 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VollunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharma Nueva
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316336
- Sponsor's protocol ID
- BE24-005
- Acronym
- BE24-005
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidential
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Multiple Dose, Two-way Crossover Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Reference Product (Xatral® XL 10 mg) in Healthy Thai Male Volunteers Under Fed Conditions
- ClinicalTrials.gov ID
- NCT06316336
- Acronym / sponsor ID
- BE24-005 / BE24-005
- Conditions
- Healthy Vollunteer
- Keywords
- Alfuzosin Hydrochloride, Bioequivalence study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Pharma NuevaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (estimated)
- Primary completion
- 22 Jun 2024 (estimated)
- Study completion
- 28 Jun 2024 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each subject will receive a single dose of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, as a test formulation (T) or a single dose of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg, as a reference formulation (R), with 240±2 mL of ambient temperature drinking water at 30 minutes after the start of standardized HFHC breakfast. Investigational product will be provided to subject in stainless steel cup and subject will be dosed without touching the tablet. This activity will be followed by a mouth check using a tongue depressor and a flashlight to assess the compliance of dosing. The formulations will be given in a crossover fashion as per the randomization schedule. The dosing processes will be conducted under normal light condition.
In each period, total of 21 blood samples will be collected from 21 sampling time points. Blood samples (6 mL each) will be collected as per the following schedule:
- Pre-dose blood sample collection (Day 1, Day 4, Day 5 and Day 6) Total of 4 pre-dose blood samples (6 mL each) will be collected from 4 pre-dose sampling time points on Day 1, Day 4, Day 5 and Day 6.
- Post-dose blood sample collection (Day 6 and Day 7) Total of 17 post-dose blood samples (6 mL each) will be collected from 17 post-dose sampling time points at 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 9.00, 10.00, 11.00, 12.00, 13.00, 14.00, 16.00 and 24.00 hours post-dose.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generic Alfuzosin Hydrochloride 10 mg | Experimental | Drug: Alfuzosin Hydrochloride 10 mg, Drug: Xatral® XL 10 mgGeneric Alfuzosin Hydrochloride 10 mg (test drug) |
| Xatral® XL 10 mg | Active comparator | Drug: Alfuzosin Hydrochloride 10 mg, Drug: Xatral® XL 10 mgXatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg (reference drug)) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfuzosin Hydrochloride 10 mgAlfuzosin Hydrochloride 10 mg (test durg) | Drug | Generic Alfuzosin Hydrochloride 10 mg, Xatral® XL 10 mg |
| Xatral® XL 10 mgAlso: Alfuzosin Hydrochloride 10 mgXatral® XL 10 mg (reference drug) | Drug | Generic Alfuzosin Hydrochloride 10 mg, Xatral® XL 10 mg |
Primary outcome
Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets
Time frame: Through Day 6 and Day 7 post dose
Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets
Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets
Time frame: Day 6 and Day 7 post dose
Peak Plasma Concentration (Cmax) of Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No. Confidential
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Porranee Puranajoti principal investigator
International Bio service
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Alfuzosin Hydrochloride 10 mg and Xatral® XL 10 mg in people with Healthy Vollunteer, run by Pharma Nueva.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aksorn Jarupintusopon (0918744146, aksorn.riengsilchai@pharmanueva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma area Under the Curve (AUC(Day 6 and Day 7)) for Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (time frame: Through Day 6 and Day 7 post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.