Prostatic HyperplasiaPhase 1NCT02417831

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

A Phase 1 study testing tamsulosin capsules 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

Search all trials

Trial summary

A bio-equivalence of 2 different capsule formulations in fasted subjects 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 capsules and tamsulosin HCl
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: No sites listed yet
Study dates: 30 Apr 2015to 31 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

Healthy male volunteers 18 years and older

Who cannot join

History of hypersensitivity or allergy to the IPM 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 Fasted Conditions

A bio-equivalence of 2 different capsule formulations in fasted subjects

Conditions: Prostatic Hyperplasia
Being tested: tamsulosin capsules, 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 capsulesDrug
tamsulosin HClDrug

Study groups in NCT02417831
Study group	Role	What they receive
tamsulosin capsules	Active comparator	Not described Receives: Drug: tamsulosin capsules
tamsulosin HCl capsules	Active comparator	Not described Receives: Drug: tamsulosin HCl

What is being measured

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

Cmax
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
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).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
(AUC0-inf)
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

Secondary outcomes (3)

Tmax
Time to maximum plasma concentration
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
λz
Terminal elimination rate constant in plasma (λz).
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
t1/2
Apparent terminal elimination half-life of the analyte in plasma (t1/2)
Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
Measured: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 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.

30 Apr 201531 May 2015

First posted16 Apr 2015 (estimated)
Study start30 Apr 2015
Primary completion31 May 2015
Study completion31 May 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: NCT02417831
Sponsor's protocol ID: 527.88
Status last verified: Apr 2020
First submitted: 13 Apr 2015
Last updated: 27 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
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

All Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 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 Fasted Conditions
ClinicalTrials.gov ID: NCT02417831
Acronym / sponsor ID: 527.88
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: 30 Apr 2015 (actual)
Primary completion: 31 May 2015 (actual)
Study completion: 31 May 2015 (actual)
First posted: 16 Apr 2015 (estimated)
Results: Posted 26 Mar 2020

Clinical summary

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

A bio-equivalence of 2 different capsule formulations in fasted subjects

Study design

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

Arm	Type	Receives
tamsulosin capsules	Active comparator	Drug: tamsulosin capsules
tamsulosin HCl capsules	Active comparator	Drug: tamsulosin HCl

Who may qualify

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

Key inclusion criteria (1 listed)

Healthy male volunteers 18 years and older

Key exclusion criteria (1 listed)

History of hypersensitivity or allergy to the IPM 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 capsules	Drug	tamsulosin capsules
tamsulosin HCl	Drug	tamsulosin HCl capsules

Primary outcome

Cmax
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
Maximum measured concentration in plasma (Cmax). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
AUC0-tz
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 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). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.
(AUC0-inf)
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 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). Geometric Coefficient of Variation (gCV) is actually inter-individual gCV.

3 secondary outcomes

Tmax
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
λz
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.
t1/2
Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.

Results and safety

Results posted to the registry on 26 Mar 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
New MR (Test) / Registered MR (Reference)	17	17
Registered MR (Reference) / New MR (Test)	17	17

Primary outcome: Cmax

Time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 8h, 10h, 12h, 16h, 24h, 36h, 48h and 72h after drug administration.. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	New MR (Test) n = 34	Registered MR (Reference) n = 34
Value	21700 (37.8)	20520 (36.7)

New MR (Test) vs Registered MR (Reference): Ratio: 105.76 (90% CI 99.81 to 112.08)

Population analysed: Pharmacokinetic set (PK set): All subjects who had evaluable pharmacokinetic (PK) data for both treatment periods were included in the statistical PK analysis for the study.

Primary outcome: AUC0-tz

Measure	New MR (Test) n = 34	Registered MR (Reference) n = 34
Value	241500 (48.4)	238200 (48.0)

New MR (Test) vs Registered MR (Reference): Ratio: 101.40 (90% CI 97.71 to 105.23)

Population analysed: PK set

Primary outcome: (AUC0-inf)

Measure	New MR (Test) n = 34	Registered MR (Reference) n = 34
Value	248200 (49.4)	244700 (48.9)

New MR (Test) vs Registered MR (Reference): Ratio: 101.42 (90% CI 97.81 to 105.17)

Population analysed: PK set

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From drug administration until 7days thereafter for each treatment arm, upto 10 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New MR (Test)	0 of 34 (0%)	6 of 34 (17.6%)	Not reported
Registered MR (Reference)	0 of 34 (0%)	9 of 34 (26.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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 capsules 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 27 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 26 Mar 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?

Cmax (time frame: Before drug administration (0 hours (h)) and 1h, 2h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 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 NCT02417831.

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 27 Apr 2020.