HypertensionPhase 1NCT01389609
Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
A Phase 1 study testing Doxazosin 4 mg Japanese marketed IR tablet, Doxazosin 4 mg ODT with water and Doxazosin 4 mg ODT without water in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.
Trial summary
To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Doxazosin 4 mg Japanese marketed IR tablet, Doxazosin 4 mg ODT with water and Doxazosin 4 mg ODT without water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2011to Aug 2011
- 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy male subjects
Who cannot join
- Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in SBP, a ≥10 mm Hg reduction in DBP and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
- Conditions
- Hypertension
- Being tested
- Doxazosin 4 mg Japanese marketed IR tablet, Doxazosin 4 mg ODT with water, Doxazosin 4 mg ODT without water
- Keywords
- Bioequivalence, Orally-disintegrating Tablet
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doxazosin 4 mg Japanese marketed IR tabletDrug
Immediate release tablet, 4 mg, single dose
Doxazosin 4 mg ODT with waterDrug
Orally-disintegrating Tablet , 4 mg, single dose with water
Doxazosin 4 mg ODT without waterDrug
Orally-disintegrating Tablet , 4 mg, single dose without water
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Doxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions Receives: Drug: Doxazosin 4 mg Japanese marketed IR tablet |
| B | Experimental | Doxazosin 4 mg ODT with water as a single oral dose under fasted conditions Receives: Drug: Doxazosin 4 mg ODT with water |
| C | Experimental | Doxazosin 4 mg ODT without water as a single oral dose under fasted conditions Receives: Drug: Doxazosin 4 mg ODT without water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Cmax) and AUC from zero to the last sampling point (AUCt) of doxazosin 4 mg Orally Disintegrating Tablet (ODT) without water compared to doxazosin 4 mg Japanese marketed Immediate Release (IR) tablet under fasted conditions
Measured: up to 48 hours
Secondary outcomes (3)
Cmax and AUCt of doxazosin 4 mg ODT with water compared to doxazosin 4 mg Japanese marketed IR tablet under fasted conditions.
Measured: up to 48 hours
Other Pharmacokinetic (PK) parameters (Tmax, AUC from zero to infinity (AUCinf), AUC from zero to the last measurable point (AUClast), elimination rate constant (Kel), t½, and mean residence time (MRT) of doxazosin under all forms of
Measured: up to 48 hours
administration.
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01389609
- Sponsor's protocol ID
- A0351069
- Status last verified
- Jan 2021
- First submitted
- 5 Jul 2011
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Single-Dose, 3-Way Crossover Study Assessing Bioequivalence Of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
- ClinicalTrials.gov ID
- NCT01389609
- Acronym / sponsor ID
- A0351069
- Conditions
- Hypertension
- Keywords
- Bioequivalence, Orally-disintegrating Tablet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Jul 2011 (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.
To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Doxazosin 4 mg Japanese marketed IR tabletDoxazosin 4 mg Japanese marketed IR tablet as a single oral dose under fasted conditions |
| B | Experimental | Drug: Doxazosin 4 mg ODT with waterDoxazosin 4 mg ODT with water as a single oral dose under fasted conditions |
| C | Experimental | Drug: Doxazosin 4 mg ODT without waterDoxazosin 4 mg ODT without water as a single oral dose under fasted conditions |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Japanese healthy male subjects
Key exclusion criteria (1 listed)
- Baseline orthostatic hypotension defined as a ≥20 mm Hg reduction in SBP, a ≥10 mm Hg reduction in DBP and/or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
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 |
|---|---|---|
| Doxazosin 4 mg Japanese marketed IR tabletImmediate release tablet, 4 mg, single dose | Drug | A |
| Doxazosin 4 mg ODT with waterOrally-disintegrating Tablet , 4 mg, single dose with water | Drug | B |
| Doxazosin 4 mg ODT without waterOrally-disintegrating Tablet , 4 mg, single dose without water | Drug | C |
Primary outcome
Peak plasma concentration (Cmax) and AUC from zero to the last sampling point (AUCt) of doxazosin 4 mg Orally Disintegrating Tablet (ODT) without water compared to doxazosin 4 mg Japanese marketed Immediate Release (IR) tablet under fasted conditions
Time frame: up to 48 hours
3 secondary outcomes
Cmax and AUCt of doxazosin 4 mg ODT with water compared to doxazosin 4 mg Japanese marketed IR tablet under fasted conditions.
Time frame: up to 48 hours
Other Pharmacokinetic (PK) parameters (Tmax, AUC from zero to infinity (AUCinf), AUC from zero to the last measurable point (AUClast), elimination rate constant (Kel), t½, and mean residence time (MRT) of doxazosin under all forms of
Time frame: up to 48 hours
administration.
Time frame: up to 48 hours
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 29 Jan 2021.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 Doxazosin 4 mg Japanese marketed IR tablet, Doxazosin 4 mg ODT with water and Doxazosin 4 mg ODT without water in people with Hypertension, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 1 site in Japan.
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 29 Jan 2021. 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 Japan. 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?
Peak plasma concentration (Cmax) and AUC from zero to the last sampling point (AUCt) of doxazosin 4 mg Orally Disintegrating Tablet (ODT) without water compared to doxazosin 4 mg Japanese marketed Immediate Release (IR) tablet under fasted conditions (time frame: up to 48 hours). 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 29 Jan 2021.