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A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

NCT ID: NCT03574285

Last Updated: 2019-05-13

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2018-10-12

Brief Summary

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A Single-dose, Comparative Bioavailability Study of Two Formulations of Sarpogrelate HCl 300mg Tablets Under Feeding Conditions

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Detailed Description

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To evaluate the bioequivalence of two formulations of Sarpogrelate HCl 300mg, Anpl-one SR Tab. 300mg (Reference) and generic Sarpogrelate HCl 300mg (Test), after a single oral dose administration in healthy Thai volunteers under feeding condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anpl-one SR Tab. 300mg

Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets

Group Type EXPERIMENTAL

Anpl-one SR Tab. 300mg

Intervention Type DRUG

Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets

Sarpodipil SR Tab. 300mg

Intervention Type DRUG

Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets

Sarpodipil SR Tab. 300mg

Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets

Group Type ACTIVE_COMPARATOR

Anpl-one SR Tab. 300mg

Intervention Type DRUG

Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets

Sarpodipil SR Tab. 300mg

Intervention Type DRUG

Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets

Interventions

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Anpl-one SR Tab. 300mg

Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets

Intervention Type DRUG

Sarpodipil SR Tab. 300mg

Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets

Intervention Type DRUG

Other Intervention Names

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Sarpogrelate HCl 300mg Sarpogrelate HCl 300mg

Eligibility Criteria

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Inclusion Criteria

* Healthy, non-smoking, male and female subjects, 19 years of age or older
* BMI ≥ 18.0 and ≤ 30.0 kg/m2.
* Females who participate in this study will be of childbearing or non-childbearing potential

Exclusion Criteria

* Know history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the investigator, would jeopardized the safety of the subject or impact the validity of the study results
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Daewoong Pharmaceutical Co. LTD.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Deawoong pharmaceutical

Seoul, Gangnam-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DDS17-035BE

Identifier Type: -

Identifier Source: org_study_id

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