Generic tamsulosin put to the test: are they truly equal?
NCT ID NCT07698288
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This study checks whether a test version of tamsulosin 0.4 mg prolonged-release tablets works the same as a reference version in healthy men aged 18 to 55. Participants take a single dose of each tablet on separate occasions after a meal, and researchers measure drug levels in the blood to see if they match. The goal is to confirm bioequivalence, which could support the use of a more affordable alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tamsulosin
- What this could lead to
- If the test tablet is shown to work the same as the reference, it could offer a more affordable or accessible option for treating enlarged prostate symptoms.
- What could go wrong
- This is a small, early-stage bioequivalence study in healthy volunteers, not patients. Results may not predict real-world effectiveness or safety differences.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
66 people
The number who actually took part.
- Started
-
Feb 2026
- Finished
-
Apr 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
"Inclusion Criteria: 1. Age between 18 and 55 years. 2. Clinically healthy male according to the updated medical history prior to the start of the study. 3. Not blocked in the COFEPRIS research subject database. 4. Body mass index between 18 and 27 kg/m². 5. Normal vital signs: Heart rate between 60 and 99 beats per minute, respiratory rate between 12 and 20 breaths per minute, systolic blood pressure between 90-130 mmHg, diastolic blood pressure between 60-89 mmHg, and temperature between 36.0 and 37.4°C. 6. Electrocardiogram (ECG) without any signs of pathology. 7. Clinical laboratory test results within normal limits or with clinically insignificant variations. 8. Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL). 9. Negative drug screening tests for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, and tetrahydrocannabinol (THC). 10. Negative breath alcohol test. 11. Research subjects with no history of alcohol abuse or dependence, psychoactive substance abuse, or chronic medication use. 12. Subjects with a signed informed consent form. Exclusion Criteria: 1. Subjects with a history of hypersensitivity to the study drug. 2. Subjects with lactose intolerance. 3. Subjects with a history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurological, endocrine, hematopoietic (any type of anemia), mental illness, or other organic abnormalities that could affect the pharmacokinetic study of the study product. 4. Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug. 5. Subjects who have been exposed to agents known to induce or inhibit hepatic enzyme systems or who have taken potentially toxic medications within 30 days prior to the start of the study. 6. Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions." 7. Subjects who have been hospitalized for any reason within sixty days prior to the start of the study or who have been seriously ill within thirty days prior to the start of the study. 8. Subjects who have received an investigational drug within ninety days prior to the start of the study. 9. Subjects who have donated or lost 450 mL or more of blood within sixty days prior to the start of the study. 10. Research subjects with a history of alcohol or psychoactive substance abuse or dependence, or chronic medication use. 11. Subjects who have consumed beverages or foods containing xanthines (coffee, tea, cocoa, chocolate, yerba mate, cola, etc.) or have consumed charcoal-grilled foods within 12 hours prior to administration of the medication dose. 12. Subjects who have consumed grapefruit, cranberry, or pomegranate juice within 12 hours prior to the study. 13. Subjects who have smoked at least 12 hours before the start of the study. 14. Subjects who have ingested alcoholic beverages 48 hours prior to administration of the dose."
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Axis Clinicals Latina, S.A. de C.V.
Mexico City, Mexico City, 07870, Mexico
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