HealthyPhase 1NCT01149733

Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

A Phase 1 study testing Tamsulosin in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

Completed

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

Trial summary

The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and Flomax® (tamsulosin hydrochloride)0.4 mg capsules (Manufactured by Yamanouchi Pharmaceutical… Read more about this study

Who is it for?: Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Tamsulosin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteCanada
Study dates: Nov 2004to Nov 2004
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 years and older
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy, non-smoking male subjects, 18 years of age or older.
BMI greater than or equal to 19 and less than or equal to 30.
Negative for:
HIV.
Hepatitis B surface antigen and Hepatitis C antibody.
Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).

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Urine cotinine test
No significant diseases or clinically significant findings in a physical examination.
No clinically significant abnormal laboratory values.
No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 60-90 mmgHg.
Be informed of the nature of the study and given written consent prior to receiving any study procedure.

Who cannot join

Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration.
Known or suspected carcinoma.
Known history or presence of:
Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity.
Alcoholism within the last 12 months.
Drug dependence and/or substance abuse.

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Use of tobacco or nicotine-containing products within the last 6 months.
Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing.
Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing.
On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
Difficulty fasting or consuming the standard meals.
Do not tolerate venipuncture.
Unable to read or sign the ICF.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Pharma Medica Research Inc.
Toronto, Ontario, M1R 5A3

Other trials in Canada

About this study

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions

Conditions: Healthy
Being tested: Tamsulosin

What participants receive

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

TamsulosinDrug
Test 0.4 mg Capsule
TamsulosinDrug
Also called Flomax®
Reference Listed 0.4 Capsule

Study groups in NCT01149733
Study group	Role	What they receive
Tamsulosin	Experimental	0.4 mg Capsule Receives: Drug: Tamsulosin
Flomax®	Active comparator	0.4 mg Capsule Receives: Drug: Tamsulosin

What is being measured

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

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax
Measured: Blood samples drawn over 60 hour period
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t
Measured: Blood samples drawn over 60 hour period
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf
Measured: Blood samples drawn over 60 hour period

Timeline

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

Nov 2004Nov 2004

First posted23 Jun 2010 (estimated)
Study startNov 2004
Primary completionNov 2004
Study completionNov 2004

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 HealthyStudies of the same condition, open and under way.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01149733
Sponsor's protocol ID: 2004-823
Status last verified: Aug 2024
First submitted: 22 Jun 2010
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
ClinicalTrials.gov ID: NCT01149733
Acronym / sponsor ID: 2004-823
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Nov 2004
Primary completion: Nov 2004 (actual)
Study completion: Nov 2004 (actual)
First posted: 23 Jun 2010 (estimated)
Results: Posted 13 Sep 2010

Clinical summary

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

Study design

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

Arm	Type	Receives
Tamsulosin	Experimental	Drug: Tamsulosin0.4 mg Capsule
Flomax®	Active comparator	Drug: Tamsulosin0.4 mg Capsule

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Healthy, non-smoking male subjects, 18 years of age or older.
BMI greater than or equal to 19 and less than or equal to 30.
Negative for:
No significant diseases or clinically significant findings in a physical examination.
No clinically significant abnormal laboratory values.

Key exclusion criteria (15 listed)

Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration.
Known or suspected carcinoma.
Known history or presence of:
Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing.
Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing.

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
TamsulosinTest 0.4 mg Capsule	Drug	Tamsulosin
TamsulosinAlso: Flomax®Reference Listed 0.4 Capsule	Drug	Flomax®

Primary outcome

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Time frame: Blood samples drawn over 60 hour period
Bioequivalence based on Cmax
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Time frame: Blood samples drawn over 60 hour period
Bioequivalence based on AUC0-t
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Time frame: Blood samples drawn over 60 hour period
Bioequivalence based on AUC0-inf

Results and safety

Results posted to the registry on 13 Sep 2010, 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	16	16
Flomax®	16	16

Primary outcome: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples drawn over 60 hour period. Mean (Standard Deviation). Unit: ng/mL

Measure	Tamsulosin n = 16	Flomax® n = 16
Value	8.8694 (28)	9.0150 (26)

Tamsulosin vs Flomax®: Ratio of Geometric Means: 97.90 (90% CI 91.00 to 105.32)

Primary outcome: AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Time frame: Blood samples drawn over 60 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Tamsulosin n = 16	Flomax® n = 16
Value	137.0248 (27)	148.9023 (28)

Tamsulosin vs Flomax®: Ratio of Geometric Means: 91.81 (90% CI 87.72 to 96.10)

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

Time frame: Blood samples drawn over 60 hour period. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Tamsulosin n = 16	Flomax® n = 16
Value	143.2749 (29)	157.9455 (30)

Tamsulosin vs Flomax®: Ratio of Geometric Means: 90.64 (90% CI 86.59 to 94.89)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tamsulosin	0 of 32 (0%)	0 of 32 (0%)	Not reported
Flomax®	0 of 32 (0%)	0 of 32 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Xueyu (Eric) Chen, M.D., Ph. D., FRCP (C) principal investigator

Pharma Medica Research, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tamsulosin in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.

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 12 inclusion and 15 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 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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 13 Sep 2010). 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 (Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples drawn over 60 hour period). 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 NCT01149733.

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 20 Aug 2024.