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A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03603132
Recruitment Status : Completed
First Posted : July 27, 2018
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Hetrombopag Olamine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets
Actual Study Start Date : July 14, 2018
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : August 17, 2018


Arm Intervention/treatment
Active Comparator: Hetrombopag Olamine A
health subjects received 7.5 mg Hetrombopag Olamine while fasting.
Drug: Hetrombopag Olamine
7.5mg in each cycle

Active Comparator: Hetrombopag Olamine B
health subjects received a high-fat meal one hour after taking7.5 mg Hetrombopag Olamine
Drug: Hetrombopag Olamine
7.5mg in each cycle

Active Comparator: Hetrombopag Olamine C
health subjects received a high-fat meal two hours after taking7.5 mg Hetrombopag Olamine
Drug: Hetrombopag Olamine
7.5mg in each cycle




Primary Outcome Measures :
  1. Adverse events [ Time Frame: from baseline up to Day 26 ]

Secondary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) [ Time Frame: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group ]
  2. Area under the plasma concentration versus time curve (AUC) [ Time Frame: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
  3. Signed informed consent.

Exclusion Criteria:

  1. Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
  2. Having deep vein thrombosis or other thrombotic diseases.
  3. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
  4. Extended QT interval during the screening period (calculated in Bazett's method, males >450 msec)
  5. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
  6. Those who have a history of allergies to drugs , food or test drugs or similar drugs;
  7. Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
  8. Those who took any drug within 14 days before the test (including Chinese herbal medicine)
  9. Any drug that inhibits or induces liver drug metabolism within 30 days before the test
  10. Subjects have participated in other clinical trial within the 3 months prior to study entry.
  11. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603132


Locations
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China, Hunan
The third xiangya hospital Hospital,of central south university
Changsha, Hunan, China, 410013
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03603132    
Other Study ID Numbers: HR-TPO-Ig
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms