Pharmacokinetics of MirabegronPhase 4NCT04501640

A Study to Investigate the Effect of Food With Mirabegron in Healthy Chinese Participants

A Phase 4 study testing mirabegron in people with Pharmacokinetics of Mirabegron and Food Effect, run by Astellas Pharma China, Inc. at 1 site in China.

Completed

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

Official record

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Trial summary

This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants. This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics of Mirabegron, Food Effect, Healthy Chinese Subjects
What is being tested?: mirabegron
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 siteChina
Study dates: 21 Sep 2020to 27 Oct 2020
Phase: Phase 4
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Subject has a body mass index range of 19.0 to 24.9 kg/m^2, inclusive and weighs at least 50 kg for male subjects and 45 kg for female subjects at screening.
Female subject is not pregnant and at least 1 of the following conditions apply:
Not a woman of childbearing potential (WOCBP)
WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 30 days after final IP administration
Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
Female subject must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration.

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Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the study period and for 30 days after final IP administration.
Male subject must not donate sperm during the study period and for 30 days after final IP administration.
Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 30 days after final IP administration.
Subject agrees not to participate in another interventional study while participating in the present study, defined as 84 days prior screening until completion of the last study visit.

Who cannot join

Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
Subject has a known or suspected hypersensitivity to mirabegron or any components of the formulation used.
Subject has had previous exposure with mirabegron.
Subject has any of the liver function tests (alkaline phosphatase, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1 of period 1.
Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.
Subject has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy.

Show all 22Show fewer

Subject has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1 of period 1.
Subject has any of the following concerns with regard to tuberculosis:
History of active tuberculosis
Abnormalities detected in a chest X-ray on day -1 of period 1
Contact with infectious tuberculous patients
Subject has any clinically significant abnormality following the physical examination, electrocardiogram (ECG) and protocol-defined clinical laboratory tests at screening or on day -1 of period 1.
Participant has a mean pulse < 45 bpm, > 99 bpm; mean body temperature < 35.0°C, > 37.5°C; mean systolic blood pressure < 90 mmHg, ≥ 140 mmHg; mean diastolic blood pressure < 40 mmHg, ≥ 90 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes) at screening or on day-1 of period 1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of: ≥ 430 msec (for male subjects) ≥ 450 msec (for female subjects) at screening or on day-1 of period 1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
Subject has used any prescribed or nonprescribed drugs (including vitamins, natural and herbal remedies, e.g., St. John's Wort and traditional Chinese medicine) in the 2 weeks prior to first IP administration, except for occasional use of paracetamol (up to 2 g/day), topical dermatological products, including corticosteroid products, hormonal contraceptives or hormone replacement therapy (HRT).
Subject has a history of smoking > 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1 of period 1.
Subject has a history of consuming > 21 units for male subjects or > 14 units for female subjects of alcohol per week within 3 months prior to day -1 of period 1 (note: 1 unit = 10 g pure alcohol, 250 mL of beer [5%], 35 mL of spirits [35%] or 100 mL of wine [12%]) or the subject has a history of alcohol-dependency, drug-dependency, chemical-dependency, or alcohol or drug abuse within 2 years prior to screening or the subject tests positive for alcohol at screening or on day -1 of period 1.
Subject has used any drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 of period 1 or the subject tests positive for drugs of abuse (amphetamines, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1 of period 1.
Subject has used any inducer of metabolism (e.g., barbiturates and rifampin) in the 3 months prior to day -1 of period 1.
Subject has had significant blood loss, donated ≥ 400 mL of whole blood within 90 days, ≥ 200 mL of whole blood within 30 days or donated blood components within 14 days prior to day -1 of period 1 and/or received a transfusion of any blood or blood products within 60 days.
Subject has a positive serology test for hepatitis A virus antibodies (immunoglobulin M), hepatitis B core antibodies, hepatitis B surface antigen, hepatitis C virus antibodies, human immunodeficiency virus or syphilis at screening.
Subject is an employee of Astellas, the study-related contract research organizations or the clinical unit.

Trial locations and contacts

1 site in 1 country.

China1 site

Site CN86001
Shanghai

Other trials in China

About this study

Official title: A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects

This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants.

This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants.

Read the detailed description

An open-label, randomized, 2-period, single oral dose crossover design at 2 dose levels in healthy Chinese male and female participants. Each participant took part in 2 periods separated by a washout of at least 10 days between investigational product (IP) administrations in each period.

Participants were screened for up to 21 days prior to IP administration on day 1 of period 1. Eligible participants were admitted to the clinical unit on day -1 of each period and were confined until the last pharmacokinetic sample had been drawn within each period. PK samples were collected predose on day 1 of each period and at multiple time points following each dose.

Conditions: Pharmacokinetics of Mirabegron, Food Effect, Healthy Chinese Subjects
Being tested: mirabegron
Keywords: mirabegron, pharmacokinetics, two-way crossover

What participants receive

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

mirabegronDrug
Also called Betmiga
Oral adminstration

Study groups in NCT04501640
Study group	Role	What they receive
Mirabegron 25 mg fed/Mirabegron 25 mg fasted	Experimental	Participants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 milligram (mg) mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period. Receives: Drug: mirabegron
Mirabegron 25 mg fasted/Mirabegron 25 mg fed	Experimental	Participants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period. Receives: Drug: mirabegron
Mirabegron 50 mg fed/Mirabegron 50 mg fasted	Experimental	Participants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period. Receives: Drug: mirabegron
Mirabegron 50 mg fasted/Mirabegron 50 mg fed	Experimental	Participants received single dose of 50 mg mirabegron under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period. Receives: Drug: mirabegron

What is being measured

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

Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron
AUCinf for mirabegron was reported for the plasma samples collected.
Measured: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron
AUClast for mirabegron was reported for the plasma samples collected.
Measured: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Maximum Concentration (Cmax) For Mirabegron
Cmax for mirabegron was reported from the plasma samples collected.
Measured: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period

Secondary outcomes (1)

Number of Participants With Adverse Events (AE)
An AE is any untoward medical occurrence in a participant administered an study drug, and which does not necessarily have to have a causal relationship with this study drug. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. An AE is considered "serious" if, in the view of either the investigator or sponsor, the event results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions results in congenital anomaly, or birth defect, requires inpatient hospitalization, other medically important AE. An AE with onset at any time from first dosing until last scheduled procedure was classified as a TEAE.
Measured: From date of informed consent signed to end of study (up to 24 days)

Timeline

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

21 Sep 202027 Oct 2020

First posted6 Aug 2020
Study start21 Sep 2020
Primary completion14 Oct 2020
Study completion27 Oct 2020

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 Pharmacokinetics of MirabegronStudies 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 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04501640
Sponsor's protocol ID: 178-MA-2294
Other IDs: CTR20201670
Status last verified: Oct 2024
First submitted: 4 Aug 2020
Last updated: 12 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 4 Open-label, Randomized, Single Oral Dose, Two-way Crossover Study to Investigate the Effect of Food on the Pharmacokinetics of Mirabegron in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT04501640
Acronym / sponsor ID: 178-MA-2294
Conditions: Pharmacokinetics of Mirabegron, Food Effect, Healthy Chinese Subjects
Keywords: mirabegron, pharmacokinetics, two-way crossover
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Astellas Pharma China, Inc.Industry (pharma, biotech, devices)
Study start: 21 Sep 2020 (actual)
Primary completion: 14 Oct 2020 (actual)
Study completion: 27 Oct 2020 (actual)
First posted: 6 Aug 2020 (actual)
Results: Posted 29 Oct 2021

Clinical summary

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

This study determined the effect of food on the pharmacokinetics (PK) of single oral doses of mirabegron in healthy Chinese male and female participants.

This study also evaluated the safety and tolerability of single oral doses of mirabegron in healthy Chinese male and female participants.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: This was a two-way crossover design with 2 period and 2 dose groups. Participants were randomized to 1 of 4 sequences dependent on dose and period assigned.

Arm	Type	Receives
Mirabegron 25 mg fed/Mirabegron 25 mg fasted	Experimental	Drug: mirabegronParticipants received single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 25 milligram (mg) mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
Mirabegron 25 mg fasted/Mirabegron 25 mg fed	Experimental	Drug: mirabegronParticipants received single dose of 25 mg mirabegron tablet under fasted condition orally, on day 1 of period 1 followed by single dose of 25 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
Mirabegron 50 mg fed/Mirabegron 50 mg fasted	Experimental	Drug: mirabegronParticipants received single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fasted condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.
Mirabegron 50 mg fasted/Mirabegron 50 mg fed	Experimental	Drug: mirabegronParticipants received single dose of 50 mg mirabegron under fasted condition orally, on day 1 of period 1 followed by single dose of 50 mg mirabegron tablet under fed condition orally, on day 1 of period 2. A washout period of 10 days was maintained between the mirabegron administrations in each period.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Subject has a body mass index range of 19.0 to 24.9 kg/m^2, inclusive and weighs at least 50 kg for male subjects and 45 kg for female subjects at screening.
Female subject is not pregnant and at least 1 of the following conditions apply:
Female subject must agree not to breastfeed starting at screening and throughout the study period and for 30 days after final IP administration.
Female subject must not donate ova starting at first dose of IP and throughout the study period and for 30 days after final IP administration.
Male subject with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the study period and for 30 days after final IP administration.

Key exclusion criteria (22 listed)

Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
Subject has a known or suspected hypersensitivity to mirabegron or any components of the formulation used.
Subject has had previous exposure with mirabegron.
Subject has any of the liver function tests (alkaline phosphatase, alanine aminotransferase [ALT], aspartate aminotransferase [AST], gamma-glutamyl transferase and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal (ULN) on day -1 of period 1.
Subject has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to first IP administration.

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
mirabegronAlso: BetmigaOral adminstration	Drug	Mirabegron 25 mg fasted/Mirabegron 25 mg fed, Mirabegron 25 mg fed/Mirabegron 25 mg fasted, Mirabegron 50 mg fasted/Mirabegron 50 mg fed, Mirabegron 50 mg fed/Mirabegron 50 mg fasted

Primary outcome

Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron
Time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
AUCinf for mirabegron was reported for the plasma samples collected.
Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron
Time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
AUClast for mirabegron was reported for the plasma samples collected.
Maximum Concentration (Cmax) For Mirabegron
Time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period
Cmax for mirabegron was reported from the plasma samples collected.

1 secondary outcome

Number of Participants With Adverse Events (AE)
Time frame: From date of informed consent signed to end of study (up to 24 days)

Results and safety

Results posted to the registry on 29 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mirabegron 25 mg Fed/Mirabegron 25 mg Fasted	6	6
Mirabegron 25 mg Fasted/Mirabegron 25 mg Fed	6	6
Mirabegron 50 mg Fed/Mirabegron 50 mg Fasted	6	6
Mirabegron 50 mg Fasted/Mirabegron 50 mg Fed	6	6

Primary outcome: Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron

Time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period. Geometric mean (Geometric Coefficient of Variation). Unit: Hour*nanogram per milliliter (h*ng/mL)

Measure	Mirabegron 25 mg Fed n = 12	Mirabegron 25 mg Fasted n = 12	Mirabegron 50 mg Fed n = 12	Mirabegron 50 mg Fasted n = 12
Value	81.8 (37.2)	143 (39.3)	263 (26.9)	429 (36.8)

Mirabegron 25 mg Fed vs Mirabegron 25 mg Fasted: Geomteric Least Squares (LS) Mean Ratio: 57.06 (90% CI 46.21 to 70.47)
Mirabegron 50 mg Fed vs Mirabegron 50 mg Fasted: Geometric LSMean Ratio: 61.42 (90% CI 52.06 to 72.47)

Population analysed: The pharmacokinetic analysis set (PKAS) consisted of all participants who received at least 1 dose of investigational product (IP) for which concentration data were available to facilitate derivation of at least 1 primary pharmacokinetic parameter.

Primary outcome: Area Under The Concentration-Time Curve (AUC) From The Time of Dosing to The Last Measurable Concentration (AUClast) For Mirabegron

Time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Mirabegron 25 mg Fed n = 12	Mirabegron 25 mg Fasted n = 12	Mirabegron 50 mg Fed n = 12	Mirabegron 50 mg Fasted n = 12
Value	63.3 (36.8)	119 (40.8)	218 (25.4)	369 (39.5)

Mirabegron 25 mg Fed vs Mirabegron 25 mg Fasted: Geomteric LSMean Ratio: 53.31 (90% CI 43.02 to 66.05)
Mirabegron 50 mg Fed vs Mirabegron 50 mg Fasted: Geomteric LSMean Ratio: 59.14 (90% CI 49.48 to 70.70)

Population analysed: PKAS Population

Primary outcome: Maximum Concentration (Cmax) For Mirabegron

Time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each period. Geometric mean (Geometric Coefficient of Variation). Unit: Nanogram per milliliter (ng/mL)

Measure	Mirabegron 25 mg Fed n = 12	Mirabegron 25 mg Fasted n = 12	Mirabegron 50 mg Fed n = 12	Mirabegron 50 mg Fasted n = 12
Value	3.07 (29.9)	7.88 (82.1)	15.9 (47.7)	33.3 (82.7)

Mirabegron 25 mg Fed vs Mirabegron 25 mg Fasted: Geometric LSMean Ratio: 38.93 (90% CI 26.78 to 56.59)
Mirabegron 50 mg Fed vs Mirabegron 50 mg Fasted: Geometric LSMean Ratio: 47.90 (90% CI 31.76 to 72.24)

Population analysed: PKAS Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From date of informed consent signed to end of study (up to 24 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mirabegron 25 mg Fed	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Mirabegron 25 mg Fasted	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Mirabegron 50 mg Fed	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Mirabegron 50 mg Fasted	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Link to results and other applicable study documents on the Astellas Clinical Trials websiteLink provided by the sponsor.
Link to plain language summary of the study on the Trial Results Summaries websiteLink provided by the sponsor.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

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.

Executive Director study director

Astellas Pharma China, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mirabegron in people with Pharmacokinetics of Mirabegron and Food Effect, 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 10 inclusion and 22 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 12 Nov 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 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 29 Oct 2021). 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?

Area Under The Concentration-Time Curve (AUC) From The Time of Dosing Extrapolated to Time Infinity (AUCinf) For Mirabegron (time frame: Day 1: predose, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 24, 36, 48, 72 and 96 hour(s) postdose of each 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 NCT04501640.

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 12 Nov 2024.