HealthyPhase 1NCT01149746
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions
A Phase 1 study testing Tamsulosin in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in Canada.
Trial summary
The objective of this study is to evaluate the comparative bioavailability between Tamsulosin Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects under fasting conditions. 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
- Dec 2004to Dec 2004
- 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 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.
About this study
Official title: A Single-Dose, Comparative Bioavailability Study of Two Formulations of Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between Tamsulosin Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects under fasting 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 mg Capsule
| 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 time 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 time 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 time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2010 (estimated)
- Study startDec 2004
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Pharmaceuticals USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Xueyu (Eric) Chen, M.D., Ph. D., FRCP (C), Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149746
- Sponsor's protocol ID
- 2004-824
- Status last verified
- Jun 2010
- First submitted
- 22 Jun 2010
- Last updated
- 23 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2010. 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 Fasting Conditions
- ClinicalTrials.gov ID
- NCT01149746
- Acronym / sponsor ID
- 2004-824
- 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
- Dec 2004
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 23 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the comparative bioavailability between Tamsulosin Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects under fasting conditions.
Study design
- 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 mg Capsule | Drug | Flomax® |
Primary outcome
Cmax (maximum observed concentration of drug substance in plasma)
Time frame: Blood samples drawn over 60 hour time 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 time 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 time period
Bioequivalence based on AUC0-inf
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2010.
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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 23 Jun 2010. 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?
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?
Cmax (maximum observed concentration of drug substance in plasma) (time frame: Blood samples drawn over 60 hour time 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?
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 23 Jun 2010.