Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride in Healthy Male Subjects

NCT02266511 | Completed Phase 1

• 1 other identifier: 527.22
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4 mg capsules in healthy male subjects. One is a commercial scale batch produced at the Nishine facility, and the other is a batch, of equal size, produced at the Norman II facility

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• Area under the concentration-time curve of the analyte in plasma at different time points (AUC)

  Up to 48 h after drug administration

• Maximum concentration of the analyte in plasma (Cmax)

  Up to 48 h after drug administration

• Time to reach the maximum concentration of the analyte in plasma (tmax)

  Up to 48 h after drug administration

• Elimination half-life (t1/2)

  Up to 48 h after drug administration

• Terminal elimination rate constant of the analyte in plasma (λz)

  Up to 48 h after drug administration

• Number of participants with clinically relevant changes in laboratory values

  Up to day 3 after last drug administration

• Number of participants with clinically relevant changes in vital signs (heart rate, orthostatic blood pressure, weight, temperature, respiration rate)

  Up to day 3 after last drug administration

• Number of participants with adverse events

  Up to day 3 after last drug administration

• Number of participants with clinically relevant changes in ECG

  Up to day 3 after last drug administration

Study Arms (2)

Sequence 1

EXPERIMENTAL

Flomax®, Nishine facility followed by Flomax®, Norman II facility

Drug: Flomax®, Norman II facility; Drug: Flomax®, Nishine facility

Sequence 2

EXPERIMENTAL

Flomax®, Norman II facility followed by Flomax®, Nishine facility

Drug: Flomax®, Norman II facility; Drug: Flomax®, Nishine facility

Interventions

Flomax®, Norman II facility DRUG

Also known as: Tamsulosin hydrochloride

Sequence 1; Sequence 2

Flomax®, Nishine facility DRUG

Also known as: Tamsulosin hydrochloride

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consents, as evidenced by signature on an Informed Consent Form approved by the investigational review board (IRB) following a full explanation of the nature and purpose of the study
• Be a healthy male of any race between 18 and 40 years of age

You may not qualify if:

• Have no clinically significant abnormalities o the basis of medical history, physical examination, and vital signs with no significant orthostatic blood pressure change, which is defined as no more than a 20 mm Hg drop in systolic blood pressure on assuming and maintaining the standing position for 3 minutes after being supine for at least 5 minutes. There should be no clinically significant symptoms associated with the orthostatic blood pressure testing procedure
• Have cardiovascular system that is within normal limits based on history, physical examination, and a 12-lead electrocardiogram (ECG)
• Have a negative test for ethanol by breathalyzer
• Have the ability to understand the requirements of the study, agree to abide by the study restrictions, and agree to return for the required assessments
• Require ambulatory assistance (e.g., canes or walkers)
• Have a history of a "first dose hypotensive episode" upon starting therapy with an alpha-blocker
• Have a history of a pathological fall (unintentional change in body position) during the last year occurring under circumstances in which normal homeostatic mechanisms would ordinarily maintain stability or syncope
• Have any medical or laboratory abnormalities (liver function tests, blood urea nitrogen, and creatinine should not be outside the reference range for the clinical laboratory). Any subject who enters into the study with laboratory abnormalities must be approved by the Medical Monitor prior to enrollment
• Have abnormal alpha-1-acid glycoprotein values (i.e., values greater than 120 mg/dL)
• Have any history of acute angina attacks during the prior 6 months
• Have any abnormality of the ECG or a history of a documented myocardial infarction (electrocardiographic changes, serum enzymes increases, and hospitalization) during the prior 6 months, or evidence of any myocardial infarction on an ECG
• Have a New York Heart Association's Functional Classification of Heart Failure Class I, II, III, or IV
• Have a prior history of endocarditis
• Use any prescription medications within 2 weeks of dosing, or over-the-counter concomitant therapies with the exception of vitamins, dietary supplements, and acetaminophen within 7 days of dosing
• Have used an investigational drug within 1 month (30 days) of the Screening Period visit

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

Tamsulosin

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

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

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 17, 2014
• Study Start: August 1, 1999
• Primary Completion: September 1, 1999
• Last Updated: October 17, 2014

Record last verified: 2014-10