HealthyPhase 1NCT02138773
A Study to Compare How Tamsulosin is Absorbed to the Body After Administration of Two Types of Tamsulosin Formulation Under Fed and Fasted Conditions in Chinese Healthy Subjects
A Phase 1 study testing Tamsulosin formulation-A and Tamsulosin formulation-B in people with Healthy and Pharmacokinetics of Tamsulosin Hydrochloride, run by Astellas Pharma China, Inc. at 1 site in China.
Trial summary
The purpose of this study is to investigate the relative bioavailability of two types of prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The safety of tamsulosin formulation is also compared. 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, Pharmacokinetics of Tamsulosin Hydrochloride
- What is being tested?
- Tamsulosin formulation-A and Tamsulosin formulation-B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to Jul 2014
- 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
- Body Mass Index (BMI=weight (kg)/height(m)2) between 19 and 24 (included)
- Body weight no less than 50 kg
- Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
Who cannot join
- Subject receiving drug treatment (including OTC) within 4 weeks prior to the first administration
- Subject with a known or suspected history of allergic condition and/or hypersensitivity to Tamsulosin, any excipients in the drug product or drugs of the same class
- Existing cardiac, haematological, hepatic, renal, gastrointestinal or any other acute or chronic disease and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
- Subject with symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20mmHg within two minutes when changing from the supine to the standing position
- Subject with sitting DBP<60mmHg or >90mmHg, and/or SBP<90mmHg or>140mmHg, and/or pulse rate (PR) <40/min or >90/min, and/or axilla temperature >37℃ or <35℃ within the screen period
- Subject with a previous history of drug abuse or subject showing any degree of drug abuse within 3 months prior to the present study
Show all 12Show fewer
- Subject with a blood donation or other plasma loss of more than 200mL or received a transfusion of any blood or blood products within 3 months prior to the start of the present study
- Subject with a treatment of plasma exchange within 4 weeks prior to the present study
- Subject participated in any other study within 3 months prior to the present study, or participated in more than 3 studies during the last 12 months prior to the start of the present study
- Subject with HBs-Ag, HCV-Ab or HIV-Ab
- Subject with a partner wish to become pregnant during the present study period and 30 days after the study
- Subject is mentally or physically disabled
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Single Dose, Open-label, Cross-over Study on Bioequivalence of Two Formulations of Tamsulosin Hydrochloride Prolonged Release Capsule (Tamsulosin Pellet From Meppel Plant and Nishine Plant) Under Fed and Fasted Conditions in Chinese Healthy Male Subjects
The purpose of this study is to investigate the relative bioavailability of two types of prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The safety of tamsulosin formulation is also compared.
Read the detailed description
There will be two studies. One study will be conducted under fed condition, and the other study will be conducted under fasted condition. Each study is a single center, randomized, single dose, open-labeled, cross-over study.
Study 1 will be conducted under fed condition:
Subjects will undergo screening evaluations to determine their eligibility within 7 days prior to the study enrollment. Subjects will be admitted to the clinical facility in the evening prior to dosing for each period. All subjects will receive tamsulosin formulation-A and formulation-B in one of two randomly assigned treatment sequences at 0.5h after the start of a standard breakfast. There will be a 7-day washout period between each dose.
Study 2 will be under fasted condition:
A single oral dose of tamsulosin formulation-A or formulation-B will be given to subjects under fasted condition (fasting for at least 10 hours since 20:00PM the night before the administration). Blood will be sampled at the same time point as in Study 1. Also, safety evaluation will be performed at the same selected times throughout the study as in Study 1.
- Being tested
- Tamsulosin formulation-A, Tamsulosin formulation-B
- Keywords
- prolonged release formulation, adrenergic blocker, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tamsulosin formulation-ADrug
Also called Harnal
oral
Tamsulosin formulation-BDrug
Also called Harnal
oral
| Study group | Role | What they receive |
|---|---|---|
| Fed, formulation-A | Experimental | drug administered at 0.5h after the start of a standard breakfast Receives: Drug: Tamsulosin formulation-A |
| Fed, formulation-B | Experimental | drug administered at 0.5h after the start of a standard breakfast Receives: Drug: Tamsulosin formulation-B |
| Fasted, formulation-A | Experimental | drug administered under fasted condition (fasting for at least 10 hours) Receives: Drug: Tamsulosin formulation-A |
| Fasted, formulation-B | Experimental | drug administered under fasted condition (fasting for at least 10 hours) Receives: Drug: Tamsulosin formulation-B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of tamsulosin (AUC0-t)
AUC0-t will be calculated according to the linear trapezoidal rule.
Measured: up to 72 hr after administration
Pharmacokinetic parameter of tamsulosin (Cmax)
Measured: up to 72 hr after administration
Secondary outcomes (4)
Pharmacokinetic parameter of tamsulosin (AUC0-∞)
Measured: up to 72 hr after administration
Pharmacokinetic parameter of tamsulosin (Tmax)
Measured: up to 72 hr after administration
Pharmacokinetic parameter of tamsulosin (T1/2)
Measured: up to 72 hr after administration
Safety evaluated by physical examinations, vital signs, electrocardiograms, laboratory assessments, and adverse events.
Measured: up to 72 hr after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startApr 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma China, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Astellas Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138773
- Sponsor's protocol ID
- 617-CL-CN3
- Status last verified
- Jul 2014
- First submitted
- 13 May 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Dose, Open-label, Cross-over Study on Bioequivalence of Two Formulations of Tamsulosin Hydrochloride Prolonged Release Capsule (Tamsulosin Pellet From Meppel Plant and Nishine Plant) Under Fed and Fasted Conditions in Chinese Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02138773
- Acronym / sponsor ID
- 617-CL-CN3
- Keywords
- prolonged release formulation, adrenergic blocker, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 15 May 2014 (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 purpose of this study is to investigate the relative bioavailability of two types of prolonged release formulation of tamsulosin hydrochloride in Chinese healthy subjects. The safety of tamsulosin formulation is also compared.
Detailed description
There will be two studies. One study will be conducted under fed condition, and the other study will be conducted under fasted condition. Each study is a single center, randomized, single dose, open-labeled, cross-over study.
Study 1 will be conducted under fed condition:
Subjects will undergo screening evaluations to determine their eligibility within 7 days prior to the study enrollment. Subjects will be admitted to the clinical facility in the evening prior to dosing for each period. All subjects will receive tamsulosin formulation-A and formulation-B in one of two randomly assigned treatment sequences at 0.5h after the start of a standard breakfast. There will be a 7-day washout period between each dose.
Study 2 will be under fasted condition:
A single oral dose of tamsulosin formulation-A or formulation-B will be given to subjects under fasted condition (fasting for at least 10 hours since 20:00PM the night before the administration). Blood will be sampled at the same time point as in Study 1. Also, safety evaluation will be performed at the same selected times throughout the study as in Study 1.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fed, formulation-A | Experimental | Drug: Tamsulosin formulation-Adrug administered at 0.5h after the start of a standard breakfast |
| Fed, formulation-B | Experimental | Drug: Tamsulosin formulation-Bdrug administered at 0.5h after the start of a standard breakfast |
| Fasted, formulation-A | Experimental | Drug: Tamsulosin formulation-Adrug administered under fasted condition (fasting for at least 10 hours) |
| Fasted, formulation-B | Experimental | Drug: Tamsulosin formulation-Bdrug administered under fasted condition (fasting for at least 10 hours) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body Mass Index (BMI=weight (kg)/height(m)2) between 19 and 24 (included)
- Body weight no less than 50 kg
- Healthy as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
Key exclusion criteria (12 listed)
- Subject receiving drug treatment (including OTC) within 4 weeks prior to the first administration
- Subject with a known or suspected history of allergic condition and/or hypersensitivity to Tamsulosin, any excipients in the drug product or drugs of the same class
- Existing cardiac, haematological, hepatic, renal, gastrointestinal or any other acute or chronic disease and/or pathological findings, which might interfere with the drug's safety, tolerability, absorption and/or pharmacokinetics
- Subject with symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20mmHg within two minutes when changing from the supine to the standing position
- Subject with sitting DBP<60mmHg or >90mmHg, and/or SBP<90mmHg or>140mmHg, and/or pulse rate (PR) <40/min or >90/min, and/or axilla temperature >37℃ or <35℃ within the screen period
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 formulation-AAlso: Harnaloral | Drug | Fasted, formulation-A, Fed, formulation-A |
| Tamsulosin formulation-BAlso: Harnaloral | Drug | Fasted, formulation-B, Fed, formulation-B |
Primary outcome
Pharmacokinetic parameter of tamsulosin (AUC0-t)
Time frame: up to 72 hr after administration
AUC0-t will be calculated according to the linear trapezoidal rule.
Pharmacokinetic parameter of tamsulosin (Cmax)
Time frame: up to 72 hr after administration
4 secondary outcomes
Pharmacokinetic parameter of tamsulosin (AUC0-∞)
Time frame: up to 72 hr after administration
Pharmacokinetic parameter of tamsulosin (Tmax)
Time frame: up to 72 hr after administration
Pharmacokinetic parameter of tamsulosin (T1/2)
Time frame: up to 72 hr after administration
Safety evaluated by physical examinations, vital signs, electrocardiograms, laboratory assessments, and adverse events.
Time frame: up to 72 hr after administration
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 16 Jul 2014.
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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.
Medical Director study director
Astellas Pharma 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 formulation-A and Tamsulosin formulation-B in people with Healthy and Pharmacokinetics of Tamsulosin Hydrochloride, run by Astellas Pharma China, Inc. at 1 site in China.
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 3 inclusion and 12 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 16 Jul 2014. 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 China. 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?
Pharmacokinetic parameter of tamsulosin (AUC0-t) (time frame: up to 72 hr after administration). The study lists 2 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 16 Jul 2014.