Healthy VolunteerPhase 1NCT06228339
The Bioequivalence Study of Alfuzosin 10 mg Prolong-released Tablets Under Fed Conditions
A Phase 1 study testing Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Xatral® XL 10 mg in people with Healthy Volunteer, run by International Bio service.
Trial summary
Objective: Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period. 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 Volunteer
- What is being tested?
- Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets and Xatral® XL 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 9 Mar 2024to 21 Mar 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 taking 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 taking a rest for at least 5 minutes each. The last measurement value should be used to determine the subject's eligibility.
- 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.
- Investigation with blood sample shows positive test for HBsAg
- Abnormal liver function, ≥1.5 times of upper normal limit of reference range for ALT, AST or bilirubin levels at screening laboratory test.
- Have eGFR (CKD-EPI) < 30 mL/min/1.73 m2 based on serum creatinine results, at the screening laboratory test or during enrollment.
- 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.
- 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.).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Subjects with poor venous access or intolerant to venipuncture
- Unwilling or unable to comply with schedule visit, treatment plan and other study procedures until end of study.
- 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.
- Subjects who are employees of International Bio Service Co., Ltd., or Sponsor.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Single Dose, Randomized, Open-label, 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
Objective:
Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period.
Study Design:
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study
Read the detailed description
This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
- Conditions
- Healthy Volunteer
- Being tested
- Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg
- Keywords
- Alfuzosin, Bioequivalence Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin Hydrochloride 10 mg Prolonged-release TabletsDrug
Also called Alfuzosin Hydrochloride 10 mg
Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug)
Xatral® XL 10 mgDrug
Also called Alfuzosin Hydrochloride 10 mg
Xatral® XL 10 mg (Reference Drug)
| Study group | Role | What they receive |
|---|---|---|
| Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets | Experimental | Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug) Receives: Drug: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets; Drug: Xatral® XL 10 mg |
| Xatral® XL 10 mg | Active comparator | Xatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets)(Reference Drug) Receives: Drug: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets; 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(0 to 48hr)) for Alfuzosin
Plasma Area Under the Curve of simvastatin acid, the active metabolite of Alfuzosin
Measured: Through 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Alfuzosin
Peak Plasma Concentration (Cmax) of Alfuzosin
Measured: 48 Hours Post Dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start9 Mar 2024 (estimated)
- Primary completion14 Mar 2024 (estimated)
- Study completion21 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- International Bio service
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Porranee Puranajoti, Principal investigator, International Bio service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228339
- Sponsor's protocol ID
- BE23-018
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, Randomized, Open-label, 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
- NCT06228339
- Acronym / sponsor ID
- BE23-018
- Conditions
- Healthy Volunteer
- Keywords
- Alfuzosin, Bioequivalence Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- International Bio serviceResearch network
- Study start
- 9 Mar 2024 (estimated)
- Primary completion
- 14 Mar 2024 (estimated)
- Study completion
- 21 Mar 2024 (estimated)
- First posted
- 29 Jan 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.
Objective:
Primary objective of the present study was to assess the relative bioavailability of Alfuzosin 10 mg Prolong-released Tablets under Fed conditions, in Healthy Thai Male Volunteers after an oral administration with 7 days washout period.
Study Design:
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study
Detailed description
This study is conducted to investigate bioequivalence information which is required to ensure therapeutic equivalence of a test product and a reference product as well as to be considered as one aspect of product quality. Bioequivalence is defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets | Experimental | Drug: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Drug: Xatral® XL 10 mgAlfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug) |
| Xatral® XL 10 mg | Active comparator | Drug: Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Drug: Xatral® XL 10 mgXatral® XL 10 mg (Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets)(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 (29 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 mg Prolonged-release TabletsAlso: Alfuzosin Hydrochloride 10 mgAlfuzosin Hydrochloride 10 mg Prolonged-release Tablets (Test Drug) | Drug | Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg |
| Xatral® XL 10 mgAlso: Alfuzosin Hydrochloride 10 mgXatral® XL 10 mg (Reference Drug) | Drug | Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets, Xatral® XL 10 mg |
Primary outcome
Plasma Area Under the Curve (AUC(0 to 48hr)) for Alfuzosin
Time frame: Through 48 Hours Post Dose
Plasma Area Under the Curve of simvastatin acid, the active metabolite of Alfuzosin
Peak Plasma Concentration (Cmax) of Alfuzosin
Time frame: 48 Hours Post Dose
Peak Plasma Concentration (Cmax) of Alfuzosin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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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 Prolonged-release Tablets and Xatral® XL 10 mg in people with Healthy Volunteer, run by International Bio service.
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 29 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 29 Jan 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 Nannapat Wannaphruek (024415211, nannapat.wan@mahidol.ac.th), 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(0 to 48hr)) for Alfuzosin (time frame: Through 48 Hours 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 29 Jan 2024.