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Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine

Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pharmacokinetics of Mirabegron and Tolterodine; Healthy

Intervention: tolterodine (Drug); mirabegron (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Medical Director, Study Chair, Affiliation: Astellas Pharma Inc


To assess the effect of multiple doses of mirabegron to postmenopausal adult female subjects on the pharmacokinetics (PK) of tolterodine and its metabolites. In addition, the safety of these products will be assessed.

Clinical Details

Official title: Post-Marketing Study of Mirabegron - A Pharmacokinetic Study to Assess Drug-Drug Interaction Between Mirabegron and Tolterodine -

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome:

Plasma concentration of unchanged mirabegron

Plasma concentration of unchanged tolterodine

Secondary outcome:

Plasma concentration of tolterodine metabolites (5-hydroxymethyl tolterodine; 5-HMT)

Safety assessed by the incidence of adverse events, vital signs, clinical labo-tests, and 12-lead ECG


Minimum age: 45 Years. Maximum age: 70 Years. Gender(s): Female.


Inclusion Criteria:

- Subjects of two years after menopause

- Body weight (at screening) ≥ 40. 0 kg and < 70. 0 kg

- Body mass index (BMI) (at screening) ≥ 17. 6 kg/m2 and < 26. 4 kg/m2

- Healthy, as judged by the investigator/sub-investigator based on medical history and

the results of physical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission (at single dosing phase) to immediately before study medication. Exclusion Criteria:

- Received or scheduled to receive any investigational drugs in other clinical trials,

post-marketing studies, or clinical studies within 120 days before the screening or during the period from the screening to hospitalization (Day −2).

- Donated or scheduled to donate 400 mL of whole blood within 90 days before the

screening or during the period from the screening to hospitalization (Day −2), 200 mL of whole blood within 30 days before the screening or during the period from the screening to hospitalization (Day −2), or blood components within 14 days before the screening or during the period from the screening to hospitalization (Day −2).

- Any deviation of the laboratory tests at screening or hospitalization (Day −2).

- A deviation from the normal range of blood pressure, pulse rae, or body temperature

at screening or hospitalization (Day - 2) Supine blood pressure: Systolic blood

pressure: ≥90 mmHg, ≤140 mmHg, Diastolic blood pressure: ≥40 mmHg, ≤90 mmHg Supine pulse rate; ≥40 bpm, ≤99 bpm Axillary body temperature; ≥35. 0°C, ≤37. 0°C

- History of drug allergies

- Upper gastrointestinal disease (e. g., nausea, vomiting, and stomachache) within 7

days before hospitalization (Day −2)

- Concurrent or previous hepatic disease (e. g., viral hepatitis, drug-induced liver

injury, and hepatic impairment)

- Concurrent or previous heart disease (e. g., congestive heart failure, angina

pectoris, and arrhythmia requiring treatment)

- Concurrent or previous GI disease (e. g., ileus paralytic, gastric atony, intestinal

atony, colitis ulcerative, peptic ulcer and gastroesophageal reflux esophagitis; except for a history of appendicitis).

- Concurrent or previous renal disease (e. g., acute renal failure, glomerulonephritis,

and interstitial nephritis)

- Concurrent or previous endocrine disease (e. g., hyperthyroidism and blood growth

hormone abnormal)

- Concurrent or previous cerebrovascular disorder (e. g., cerebral infarction)

- Previous use of mirabegron or tolterodine

- Excessive smoking or drinking habit

Locations and Contacts

Kanto, Japan
Additional Information

Starting date: June 2013
Last updated: October 15, 2013

Page last updated: August 23, 2015

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