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BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

Primary Purpose

Intermittent Claudication

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cilostazol Tablet 100 mg
PMR Tablet 135 mg
Sponsored by
Genovate Biotechnology Co., Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intermittent Claudication focused on measuring Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be 18 to 45 years of age, inclusive, at screening.
  • Absence of diseases that could affect the study outcomes.
  • Having a body mass index (BMI) between 18.5 and 29.9, inclusive, at screening.
  • Females must have a negative serum pregnancy test at screening.
  • Understanding and willing to participate in the clinical study and able to comply with study procedures and visits.

Exclusion Criteria:

  • History of bleeding tendency.
  • Use of anticoagulant agent(s) within one (1) month prior to screening.
  • Use of tobacco or nicotine products within six (6) months of screening.
  • Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization.
  • On any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
  • History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within one (1) year prior to screening.
  • Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (3) months of screening.
  • Positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at any time during the study, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19).
  • Pregnant or breast feeding.
  • Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:

    1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
    2. Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
    3. Are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation.
  • Known or suspected hypersensitivity to any ingredient of the study drug(s).
  • Donated blood or lost more than 150 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.

Sites / Locations

  • Bio-Kinetic Clinical Applications, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Treatment RTRT (R: Cilostazol, T: PMR)

Treatment TRTR (T: PMR, R: Cilostazol)

Arm Description

Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment RTRT

Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment TRTR

Outcomes

Primary Outcome Measures

Area under the curve, from time zero to last measureable time point (AUC 0-t )
AUC from time zero to infinity (AUC 0-∞)

Secondary Outcome Measures

Full Information

First Posted
July 18, 2022
Last Updated
April 12, 2023
Sponsor
Genovate Biotechnology Co., Ltd.,
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1. Study Identification

Unique Protocol Identification Number
NCT05466734
Brief Title
BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Official Title
An Open-Label, Randomized, Two-Treatment, Two-Sequence, Four-Period, Fully Replicated Crossover Bioequivalence Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genovate Biotechnology Co., Ltd.,

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study is designed to evaluate the bioequivalence and the within-subject variability between the test formulation of extended-release tablet of cilostazol (PMR) administered once daily and the reference formulation of immediate- release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment RTRT (R: Cilostazol, T: PMR)
Arm Type
Other
Arm Description
Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment RTRT
Arm Title
Treatment TRTR (T: PMR, R: Cilostazol)
Arm Type
Other
Arm Description
Treatment R: One Cilostazol Tablet 100 mg at 08:00 and another at 20:00 Treatment T: Two PMR Tablet 135 mg at 08:00 Four-period dosing following the sequence of Treatment TRTR
Intervention Type
Drug
Intervention Name(s)
Cilostazol Tablet 100 mg
Other Intervention Name(s)
Treatment R
Intervention Description
Two oral doses (total daily dose of 200 mg)
Intervention Type
Drug
Intervention Name(s)
PMR Tablet 135 mg
Other Intervention Name(s)
Treatment T
Intervention Description
Single oral dose (total daily dose of 270 mg)
Primary Outcome Measure Information:
Title
Area under the curve, from time zero to last measureable time point (AUC 0-t )
Time Frame
0-72 hours after morning dose
Title
AUC from time zero to infinity (AUC 0-∞)
Time Frame
0-72 hours after morning dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be 18 to 45 years of age, inclusive, at screening. Absence of diseases that could affect the study outcomes. Having a body mass index (BMI) between 18.5 and 29.9, inclusive, at screening. Females must have a negative serum pregnancy test at screening. Understanding and willing to participate in the clinical study and able to comply with study procedures and visits. Exclusion Criteria: History of bleeding tendency. Use of anticoagulant agent(s) within one (1) month prior to screening. Use of tobacco or nicotine products within six (6) months of screening. Intake of over the counter (OTC) or prescription drugs (other than hormonal contraceptives) within two (2) weeks prior to randomization. On any investigational drug(s) or therapeutic device(s) within thirty (30) days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products). History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within one (1) year prior to screening. Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); known history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within three (3) months of screening. Positive test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at any time during the study, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19). Pregnant or breast feeding. Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria: Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than twelve (12) months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR; Six (6) weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR; Are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation, hysterectomy), hormonal contraception (e.g. implantable, injectable, vaginal, patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for seven (7) days after study discontinuation. Known or suspected hypersensitivity to any ingredient of the study drug(s). Donated blood or lost more than 150 mL of blood within three (3) months prior to randomization or plans to donate blood or plasma within four (4) weeks after completion of the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kayce Morton
Organizational Affiliation
Bio-Kinetic Clinical Applications, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bio-Kinetic Clinical Applications, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States

12. IPD Sharing Statement

Learn more about this trial

BE Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers

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