Study to assess the bioequivalence between ticagrelor orodispersible tablets and ticagrelor immediate-release tablets in Japanese subjects

Study identifier:D5139C00004

ClinicalTrials.gov identifier:NCT02436577

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

An open-label, randomized, three-period, three-treatment, crossover, single-centre, single-dose study to assess the bioequivalence between Ticagrelor orodispersible tablets and Ticagrelor immediate-release tablets in healthy Japanese subjects.

Medical condition

bioequivalence, healthy Japanese subjects, pharmacokinetics

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water, Ticagrelor OD tablet (90 mg single dose) administered without water, Ticagrelor IR tablet (90 mg) administered with 150 mL of water

Sex

All

Actual Enrollment

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 02 Jun 2015

Primary Completion Date: 31 Aug 2015

Study Completion Date: 31 Aug 2015

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Sept 2017 by AstraZeneca

Collaborators

Inclusion and exclusion 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

- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the potential subject at risk because of participation in the study, or influences the results or the potential subject’s ability to participate in the study.
- 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.

No locations available

Arms	Assigned Interventions
Experimental: Sequence ABC Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment B Drug: Ticagrelor IR tablet (90 mg) administered with 150 mL of water Ticagrelor 90 mg IR tablet, single dose Other Name: Treatment C
Experimental: Sequence BCA Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment B Drug: Ticagrelor IR tablet (90 mg) administered with 150 mL of water Ticagrelor 90 mg IR tablet, single dose Other Name: Treatment C
Experimental: Sequence CAB Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment B Drug: Ticagrelor IR tablet (90 mg) administered with 150 mL of water Ticagrelor 90 mg IR tablet, single dose Other Name: Treatment C
Experimental: Sequence ACB Treatment A in Period 1, Treatment C in Period 2 and Treatment B in Period 3	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment B Drug: Ticagrelor IR tablet (90 mg) administered with 150 mL of water Ticagrelor 90 mg IR tablet, single dose Other Name: Treatment C
Experimental: Sequence BAC Treatment B in Period 1, Treatment A in Period 2 and Treatment C in Period 3	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment B Drug: Ticagrelor IR tablet (90 mg) administered with 150 mL of water Ticagrelor 90 mg IR tablet, single dose Other Name: Treatment C
Experimental: Sequence CBA Treatment C in Period 1, Treatment B in Period 2 and Treatment A in Period 3	Drug: Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment A Drug: Ticagrelor OD tablet (90 mg single dose) administered without water Ticagrelor 90 mg OD tablet, single dose Other Name: Treatment B Drug: Ticagrelor IR tablet (90 mg) administered with 150 mL of water Ticagrelor 90 mg IR tablet, single dose Other Name: Treatment C

Documents available

d5139c00004 CSP redacted
Download
Pharmacokinetic profiles of ticagrelor orodispersible tables in healthy Western and Japanese subjects; . Clin Drug Investig Epub online 30 Aug 2017
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

PAREXEL International Volunteer Recruitment

+0800 38 98