Prostatic HyperplasiaPhase 1NCT02417844

Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.

A Phase 1 study testing tamsulosin (Astellas) and Tamsulosin HCL in people with Prostatic Hyperplasia, run by Boehringer Ingelheim.

Completed

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

Official record

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Trial summary

Two tamsulosin HClformulations will be tested in fed state Read more about this study

Who is it for?: Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for: Prostatic Hyperplasia
What is being tested?: tamsulosin (Astellas) and Tamsulosin HCL
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: No sites listed yet
Study dates: Apr 2015to May 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Health male volunteers 18 years and older

Who cannot join

History of hypersensitivity or allergy to IMP or its excipients or any related medication

About this study

Official title: Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions

Two tamsulosin HClformulations will be tested in fed state

Conditions: Prostatic Hyperplasia
Being tested: tamsulosin (Astellas), Tamsulosin HCL
Medical subject headings: Prostatic Hyperplasia

What participants receive

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

tamsulosin (Astellas)Drug
Tamsulosin HCLDrug

Study groups in NCT02417844
Study group	Role	What they receive
Tamsulosin HCl	Active comparator	Not described Receives: Drug: Tamsulosin HCL
Tamsulosin	Active comparator	Not described Receives: Drug: tamsulosin (Astellas)

What is being measured

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

Maximum Measured Concentration (Cmax)
Maximum measured concentration of analyte in plasma (Cmax)
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Secondary outcomes (3)

Time to Maximum Plasma Concentration (Tmax)
Time from last dosing to the maximum plasma concentration (tmax).
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Terminal Elimination Rate Constant (λz)
Terminal elimination rate constant in plasma (λz)
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Apparent Terminal Elimination Half-life (t1/2)
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Timeline

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

Apr 2015May 2015

First posted16 Apr 2015 (estimated)
Study startApr 2015
Primary completionMay 2015
Study completionMay 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02417844
Sponsor's protocol ID: 527.89
Status last verified: Apr 2020
First submitted: 13 Apr 2015
Last updated: 17 Apr 2020
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
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Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Single Center, Single Dose, Open-label, Randomized, Two-way Crossover Study to Determine Bioequivalence of Two Formulations Containing Tamsulosin HCl 04.mg MR Capsules in at Least 30 Healthy Male Subjects Under Fed Conditions
ClinicalTrials.gov ID: NCT02417844
Acronym / sponsor ID: 527.89
Conditions: Prostatic Hyperplasia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 16 Apr 2015 (estimated)
Results: Posted 17 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Two tamsulosin HClformulations will be tested in fed state

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tamsulosin HCl	Active comparator	Drug: Tamsulosin HCL
Tamsulosin	Active comparator	Drug: tamsulosin (Astellas)

Who may qualify

Ages: 18 to 64 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Health male volunteers 18 years and older

Key exclusion criteria (1 listed)

History of hypersensitivity or allergy to IMP or its excipients or any related medication

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
tamsulosin (Astellas)	Drug	Tamsulosin
Tamsulosin HCL	Drug	Tamsulosin HCl

Primary outcome

Maximum Measured Concentration (Cmax)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Maximum measured concentration of analyte in plasma (Cmax)
Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz)
Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).

3 secondary outcomes

Time to Maximum Plasma Concentration (Tmax)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Terminal Elimination Rate Constant (λz)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration
Apparent Terminal Elimination Half-life (t1/2)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration

Results and safety

Results posted to the registry on 17 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tamsulosin HCl (Test) / Flomax Relief (Reference)	17	17
Flomax Relief (Reference) / Tamsulosin HCl (Test)	17	17

Primary outcome: Maximum Measured Concentration (Cmax)

Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Tamsulosin HCl (Test) n = 34	Flomax Relief (Reference) n = 34
Value	8826 (31.8)	8856 (34.0)

Tamsulosin HCl (Test) vs Flomax Relief (Reference): Geometric mean ratio (%): 99.66 (90% CI 92.19 to 107.74)

Population analysed: Pharmacokinetic (PK) set which included all subjects who had evaluable PK data for both treatment periods.

Primary outcome: Area Under the Concentration-time Curve From 0 to the Time of the Last Quantifiable Concentration (AUC0-tz)

Measure	Tamsulosin HCl (Test) n = 34	Flomax Relief (Reference) n = 34
Value	164700 (42.4)	165400 (43.7)

Tamsulosin HCl (Test) vs Flomax Relief (Reference): Geometric mean ratio (%): 99.58 (90% CI 94.23 to 105.24)

Population analysed: PK set

Primary outcome: Area Under the Concentration-time Curve From 0 Extrapolated to Infinity (AUC0-inf)

Measure	Tamsulosin HCl (Test) n = 34	Flomax Relief (Reference) n = 34
Value	170100 (44.1)	171000 (45.2)

Tamsulosin HCl (Test) vs Flomax Relief (Reference): Geometric mean ratio (%): 99.48 (90% CI 93.90 to 105.39)

Population analysed: PK set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 72 hours. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tamsulosin HCl (Test)	0 of 34 (0%)	5 of 34 (14.7%)	Not reported
Flomax Relief (Reference)	0 of 34 (0%)	1 of 34 (2.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tamsulosin (Astellas) and Tamsulosin HCL in people with Prostatic Hyperplasia, 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 1 inclusion and 1 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 Apr 2020. 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?

Yes. Results are posted in the registry (first posted 17 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Measured Concentration (Cmax) (time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 4h, 5h, 6h, 6.5h, 7h, 7.5h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration). The study lists 3 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 NCT02417844.

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 Apr 2020.