A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects
An Open-label, Randomized, Three-period, Crossover, Single-dose Study to Evaluate the Effect of a Low-fat Meal and a Standard Meal on the Pharmacokinetics of DBPR108 in Healthy Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Liyan Miao, Professor
- Phone Number: +86-0512-67972858
- Email: sdfyy8040@126.com
Study Locations
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-
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Suzhou, China
- First Affiliated Hospital of Soochow University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
- Healthy male and/or female subjects between the ages of 18 and 45 years (inclusive);
- Body Mass Index (BMI) of 18 to 28 kg/m2 (inclusive), body weight for male ≥50.0 kg and for female≥45.0 kg;
- Subjects (including their partners) are willing to use effective contraceptives from screening to the 6 months after the last dose administration;
- Subjects judged to be in good health by the investigator, based on the physical examination, vital signs examination, 12-lead electrocardiogram (ECG) examination and laboratory examination etc;
Exclusion Criteria:
- History of allergic conditions, or allergic to any ingredients of DBPR108;
- History of severe diseases, such as cardiovascular, respiratory, liver, gastrointestinal, endocrine, hematological, psychiatric/neurological systems diseases within 1 year prior to screening;
- History of hypoglycemia or abnormal blood glucose at screening: fasting blood glucose <70 mg/dL (3.9 mmol/L) or >110 mg/dL (6.1 mmol/L);
- Subjects who have previously undergone surgery (e.g., subtotal gastrectomy) that may affect the absorption, distribution, metabolism, or excretion of the drug, or who have a scheduled surgery during the study period;
- History of drug abuse, or urine drug screening is positive at screening;
- Smoking more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using nicotine-containing products during the study period;
- Regular alcohol consumption exceeding 15 g/day(female) or 25 g/day(male) (15 g ≈ 450 mL beer, or 50 mL hard liquor, or 150 mL wine) within the 3 months prior to screening, or taking any product containing alcohol within 48 h before dosing, or alcohol test is positive;
- Blood donation (or blood loss) ≥400 mL, or receiving blood product transfusion within 3 months prior to screening;
- Consumption of grapefruit juice, methylxanthine-rich food or beverage (such as coffee, tea, cola, chocolate, energy drinks), or those who have had strenuous exercise, or have other factors affecting drug absorption, distribution, metabolism, excretion, within 48 h before the administration;
- Use of any prescription drug, over-the-counter drug (except acetaminophen and some nasal sprays), or herbal medicine within 2 weeks prior to screening;
- Have special dietary requirements and cannot consume the study meals;
- Subject with hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody or Treponema pallidum antibody positive;
- Enrolled in any other clinical trial within 3 months before screening (whichever is administrated);
- Have been vaccinated within 4 weeks prior to screening or who have a scheduled vaccination during the study period;
- Pregnant/lactating woman, or who has a positive blood pregnancy test at screening;
- Not suitable for this study as decided by the investigator due to other reasons.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Sequence A administered DBPR108
Subjects will receive a single dose of DBPR108 100 mg under fasted condition, following a low-fat meal and a standard meal.
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Drug: DBPR108, tablets, oral
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Experimental: Sequence B administered DBPR108
Subjects will receive a single dose of DBPR108 100 mg following a low-fat meal and standard meal, under fasted condition.
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Drug: DBPR108, tablets, oral
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Experimental: Sequence C administered DBPR108
Subjects will receive a single dose of DBPR108 100 mg following a standard meal, under fasted condition, following a low-fat meal.
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Drug: DBPR108, tablets, oral
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Peak plasma concentration (Cmax) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
|
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Area under the plasma concentration versus time curve from time zero to the time of last measurable concentration (AUClast) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
|
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Area under the plasma concentration versus time curve from time zero to infinity (AUCinf) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to achieve maximum plasma concentration (Tmax) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Half-life (t1/2) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Apparent clearance (CL/F) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Apparent volume of Distribution (Vz/F) of DBPR108
Time Frame: Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Predose and at prespecified time point after DBPR108 dosing on Day 1, Day 5 and Day 9.
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Number of subjects with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: Day 1 to Day 14
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Day 1 to Day 14
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- HA1118-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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