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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Anpl-one SR Tab. 300mg; Drug: Sarpodipil SR Tab. 300mg

• Registration Number: NCT03573622
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief Summary

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

Detailed Description

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 volunteers under fasting condition: open label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover, comparative bioavailability study

Study Timeline

• Study Start: 2018-05-31
• Status Verified: 2018-06
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Primary Completion: 2018-08-21
• Study Completion: 2018-10-12
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration	0-24hr	Cmax
Area under the plasma concentration versus time curve	0-24hr	AUC

Trial Locations

Locations (1)

Daewoong pharmatceutical; 🇰🇷 Seoul, Gangnam-gu, Korea, Republic of