AzTrials
AzTrials

HealthyPhase 1NCT02266511

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

A Phase 1 study testing Flomax®, Norman II facility and Flomax®, Nishine facility in people with Healthy, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Flomax®, Norman II facility and Flomax®, Nishine facility
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
Aug 1999to Sep 1999
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 40 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • Have a body weight within 10 % of normal for sex, height, and frame as specified by the Body Weight Nomogram for Inclusion/Exclusion Criteria
  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • Donated blood within 1 month of entering study
  • Have a known history of any of the following:
  • Clinically significant renal disease (renal dysfunction; i.e., creatinine greater than or equal to 2.0 mg/dL)
  • Severe cardiovascular disease (coarctation of the aorta, severe cardiac failure, second or third degree heart block, or severe angina)
  • Pulmonary disease (chronic lung disease or emphysema of a degree that could cause functional abnormalities of the right heart)
  • Have acute illness (e.g., acute upper respiratory infection) within 2 weeks prior to the start of the study
  • Have any medical condition that might interfere with either the absorption, distribution, metabolism, or excretion of tamsulosin
  • Have a history of any illness or allergy that, in the opinion of the Investigator, might confound the results of the study or pose additional risk in administering Flomax® to the subject
  • Have a history of liver disease or any physical findings suggestive of liver disease
  • Have smoked within the last 3 months or be known as or be suspected as an alcohol abuser or illicit drug user within the past year, or have a positive urine drug screen
  • Exhibit, in the opinion of the Investigator, the signs or symptoms of an immunodeficiency syndrome, whether spontaneously acquired, congenital, or iatrogenic (These syndromes are characterized by unusual susceptibility to infection [bacterial, viral, or fungal], the occurrence of autoimmune disease, and lymphoreticular malignancies)
  • Have calculated creatinine clearance less than 90 mL/min based upon the following formula:
  • Creatinine Clearance = (140 - age in years) (weight in kg) / (72) (serum creatinine)
  • Have a history of cancer except for nonmelanoma skin cancer treated by excision

About this study

Official title: A Single-dose, Randomized, Two-treatment, Two-period, Open-label, Crossover Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride 0.4-mg Capsules in Healthy Male Subjects

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
Being tested
Flomax®, Norman II facility, Flomax®, Nishine facility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flomax®, Norman II facilityDrug

    Also called Tamsulosin hydrochloride

  • Flomax®, Nishine facilityDrug

    Also called Tamsulosin hydrochloride

Study groups in NCT02266511
Study groupRoleWhat they receive
Sequence 1ExperimentalFlomax®, Nishine facility followed by Flomax®, Norman II facility
Receives: Drug: Flomax®, Norman II facility; Drug: Flomax®, Nishine facility
Sequence 2ExperimentalFlomax®, Norman II facility followed by Flomax®, Nishine facility
Receives: Drug: Flomax®, Norman II facility; Drug: Flomax®, Nishine facility

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 48 h after drug administration

  2. Maximum concentration of the analyte in plasma (Cmax)

    Measured: Up to 48 h after drug administration

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

    Measured: Up to 48 h after drug administration

  4. Elimination half-life (t1/2)

    Measured: Up to 48 h after drug administration

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

    Measured: Up to 48 h after drug administration

  6. Number of participants with clinically relevant changes in laboratory values

    Measured: Up to day 3 after last drug administration

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

    Measured: Up to day 3 after last drug administration

  8. Number of participants with adverse events

    Measured: Up to day 3 after last drug administration

  9. Number of participants with clinically relevant changes in ECG

    Measured: Up to day 3 after last drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2014 (estimated)
  2. Study startAug 1999
  3. Primary completionSep 1999

Resources

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
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266511
Sponsor's protocol ID
527.22
Status last verified
Oct 2014
First submitted
16 Oct 2014
Last updated
17 Oct 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Flomax®, Norman II facility and Flomax®, Nishine facility in people with Healthy, run by Boehringer Ingelheim.

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 7 inclusion and 25 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: finished, as of the sponsor's last update on 17 Oct 2014. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area under the concentration-time curve of the analyte in plasma at different time points (AUC) (time frame: Up to 48 h after drug administration). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02266511.

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 17 Oct 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in