Clinical Study to Determine Bioequivalence of Oral Tamsulosin Products as 0.4 mg Prolonged-release Tablets in Male Subjects Under Fasted Conditions

NCT07698275 | Completed

• 1 other identifier: ACL25-PC006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, longitudinal, single-dose, randomized, open-label, crossover 2x4, replicated, two treatments, four periods, two sequences controlled clinical study

Conditions

Bioequivalance

Keywords

Tamsulosin; pharmacokinetics; bioequivalence

Outcome Measures

Primary Outcomes (2)

• Bioequivalence based on the pharmacokinetic parameter: Cmax

  Bioequivalence based on the pharmacokinetic parameter: Cmax

  Through 72 Hours Post Dose

• Bioequivalence based on the pharmacokinetic parameter: AUC0-t

  Bioequivalence based on the pharmacokinetic parameter: AUC0-t

  Through 72 hours Post Dose

Secondary Outcomes (4)

• Characterize the pharmacokinetic parameter: AUC0-inf

  Through 72 Hours Post Dose

• Characterize the pharmacokinetic parameter: time to maximum concentration (tmax)

  Through 72 Hours Post Dose

• Characterize the pharmacokinetic parameter: elimination constant (Ke)

  Through 72 Hours Post Dose

• Establish the frequency, severity, and seriousness of adverse events that occurred during the study

  Until the final visit (7 days after the last dose)

Study Arms (2)

Reference

ACTIVE COMPARATOR

Omnic Ocas, 0.4 mg, ER tablet, Reference

Drug: TAMSULOSIN TEST

Test

EXPERIMENTAL

Tamsulosin 0.4 mg ER tablet, test

Drug: OMNIC OCAS REFERENCE

Interventions

OMNIC OCAS REFERENCE DRUG

Omnic Ocas, 0.4 mg, ER tablet, Reference

Test

TAMSULOSIN TEST DRUG

Tamsulosin 0.4 mg ER tablet, test

Reference

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Therapeutic indication of the study drug.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 55 years.
• Clinically healthy male according to the updated medical history prior to the start of the study.
• Not blocked in the COFEPRIS research subject database.
• Body mass index between 18 and 27 kg/m².
• 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.
• Electrocardiogram (ECG) without any signs of pathology.
• Clinical laboratory test results within normal limits or with clinically insignificant variations.
• Negative biosafety tests for the presence of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and varicella-zoster virus (VDRL).
• Negative drug screening tests for amphetamines, benzodiazepines, cocaine, methamphetamines, morphine, and tetrahydrocannabinol (THC).
• Negative breath alcohol test.
• Research subjects with no history of alcohol abuse or dependence, psychoactive substance abuse, or chronic medication use.
• Subjects with a signed informed consent form.

You may not qualify if:

• Subjects with a history of hypersensitivity to the study drug.
• Subjects with lactose intolerance.
• 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.
• Subjects requiring any medication during the course of the study that interferes with the quantification or pharmacokinetics of the study drug.
• 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.
• Subjects who, prior to receiving the study drug, have taken medications such as those described in section 3.11 "Drug Interactions."
• 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.
• Subjects who have received an investigational drug within ninety days prior to the start of the study.
• Subjects who have donated or lost 450 mL or more of blood within sixty days prior to the start of the study.
• Research subjects with a history of alcohol or psychoactive substance abuse or dependence, or chronic medication use.
• 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.
• Subjects who have consumed grapefruit, cranberry, or pomegranate juice within 12 hours prior to the study.
• Subjects who have smoked at least 12 hours before the start of the study.
• Subjects who have ingested alcoholic beverages 48 hours prior to administration of the dose.

Sponsors & Collaborators

• ADIUM: lead

Study Sites (1)

Axis Clinicals Latina, S.A. de C.V.

Mexico City, Mexico City, 0870, Mexico

Location

Related Publications (1)

• Accennato VAC, Costa F, Riccio MF, Bernasconi G, Noboli AC. Bioequivalence Between Two Fixed Dose Combinations of Dutasteride and Tamsulosin in Male Subjects Under Fasting and Fed Conditions. Int Ann Med. 2017;1(10).

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: January 12, 2026
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Upon request
• Access Criteria: Upon request

Locations

ME (1)