Study to Assess the Bioequivalence Between Ticagrelor Orodispersible Tablets and Ticagrelor Immediate-release Tablets in Japanese Subjects

NCT ID: NCT02436577

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2015-08-31

Brief Summary

This study will be an open-label, randomised, three-period, three-treatment, crossover study in healthy Japanese male and female of non-childbearing potential subjects, performed at a single study centre.

The objective of the study is to assess the bioequivalence of ticagrelor orodispersible (OD) tablets when administered with water and without water and ticagrelor immediate-release (IR) tablets.

Detailed Description

Study to evaluate the bioequivalence of ticagrelor orodispersible (OD) tablets administered with water and without water and ticagrelor immediate-release (IR) tablets.

Conditions

Bioequivalence; Healthy Japanese Subjects; Pharmacokinetics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Sequence ABC

Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg IR tablet, single dose

Sequence BCA

Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg IR tablet, single dose

Sequence CAB

Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg IR tablet, single dose

Sequence ACB

Treatment A in Period 1, Treatment C in Period 2 and Treatment B in Period 3

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg IR tablet, single dose

Sequence BAC

Treatment B in Period 1, Treatment A in Period 2 and Treatment C in Period 3

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg IR tablet, single dose

Sequence CBA

Treatment C in Period 1, Treatment B in Period 2 and Treatment A in Period 3

Group Type: EXPERIMENTAL

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor OD tablet (90 mg single dose) administered without water

Intervention Type: DRUG

Ticagrelor 90 mg OD tablet, single dose

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Intervention Type: DRUG

Ticagrelor 90 mg IR tablet, single dose

Interventions

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water

Ticagrelor 90 mg OD tablet, single dose

Intervention Type: DRUG

Ticagrelor OD tablet (90 mg single dose) administered without water

Ticagrelor 90 mg OD tablet, single dose

Intervention Type: DRUG

Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Ticagrelor 90 mg IR tablet, single dose

Intervention Type: DRUG

Other Intervention Names

Treatment A; Treatment B; Treatment C

Eligibility Criteria

Inclusion Criteria

• Healthy male and female subjects aged 20 to 45 years with suitable veins for cannulation or repeated venepuncture.
• Be Japanese. Japanese is defined as having both parents and four grandparents who are Japanese. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan.
• Females must have a negative pregnancy test at screening and on each admission to the clinical unit, must not be lactating, and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria:

• Postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and FSH levels in the postmenopausal range.
• Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
• Have a body mass index (BMI) between 18.0 and 27.0 kg/m2 inclusive and weigh at least 45 kg and no more than 85 kg inclusive.
• Be able and willing to communicate with the investigator and comply with all study procedures, including reproductive restrictions.

Exclusion Criteria

• Current smokers or those who have smoked or used nicotine products within the previous 3 months.
• History of hemophilia, von Willebrand's disease, lupus anticoagulant, or other diseases/syndromes that can either alter or increase the propensity for bleeding.
• A personal history of vascular abnormalities including aneurysms; a personal history of severe hemorrhage, hematemesis, melena, hemoptysis, severe epistaxis, severe thrombocytopenia, intracranial hemorrhage; or rectal bleeding within 1 year prior to screening; or history suggestive of peptic ulcer disease; or at the discretion of the investigator.
• History of a clinically significant non-traumatic bleed or clinically significant bleeding risk, as judged by the investigator.
• Use of aspirin, ibuprofen, non-steroidal anti-inflammatory drugs (NSAIDs), or any other drug known to increase the propensity for bleeding for 2 weeks before randomization.
• Platelet count less than 150 x 10^9/L.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Annelize Koch, Dr.

Role: PRINCIPAL_INVESTIGATOR

PAREXEL Early Phase Clinical Unit London

Locations

Research Site

Harrow, , United Kingdom

Countries

United Kingdom

Other Identifiers

D5139C00004

Identifier Type: -

Identifier Source: org_study_id