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An Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Volunteers

NCT ID: NCT00721448

Last Updated: 2010-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-08-31

Brief Summary

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This will be a single centre study conducted at the 3rd hospital affiliated to Peking University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited to obtain at least 20 evaluable volunteers. The primary objective of this study is to characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese volunteers. The secondary objective of this study is to determine the safety and tolerability of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical examination, clinical laboratory tests, vital signs, and collection of adverse events in healthy Chinese volunteers.

Detailed Description

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Conditions

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Pharmacokinetics

Keywords

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Pharmacokinetics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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AZD6140

90mg tablet, oral, once daily for the first day and twice daily from day 4 to 9

Intervention Type DRUG

AZD6140

90 x 2 mg tablets, oral, once daily for the first day and twice daily from day 4 to 9

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chinese ethnicity defined as having both parents and 4 grandparents who are Chinese
* Have a normal Body size and weigh at least 50 kg

Exclusion Criteria

* History of diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs determined by the investigator
* Current and/or past history of intolerance or hypersensitivity to drugs with a similar chemical structure or mechanism of action to AZD6140 or any ingredient in its formulation
* Symptoms of any clinically significant illness within 2 weeks of screening
* A personal or family history of bleeding diatheses or a reasonable suspicion of vascular abnormalities including aneurysms
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Pharmaceuticals

Principal Investigators

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Stephen Gillette

Role: STUDY_DIRECTOR

AZ Pharmaceuticals - US

Li Haiyan, MD

Role: PRINCIPAL_INVESTIGATOR

3rd hospital affiliated to Peking University

Locations

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Research Site

Beijing, , China

Site Status

Countries

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China

References

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Li H, Butler K, Yang L, Yang Z, Teng R. Pharmacokinetics and tolerability of single and multiple doses of ticagrelor in healthy Chinese subjects: an open-label, sequential, two-cohort, single-centre study. Clin Drug Investig. 2012 Feb 1;32(2):87-97. doi: 10.2165/11595930-000000000-00000.

Reference Type DERIVED
PMID: 22168538 (View on PubMed)

Other Identifiers

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D5130C00054

Identifier Type: -

Identifier Source: org_study_id