A Study to Evaluate the Multiple Dose Ascending of PG-033 in Healthy Adult Participants.
A Single-center, Randomized, Double-blind, Placebo-controlled, Dose Escalation Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PG-033 by Multiple Dose Administration in Healthy Adult Participants .
調査の概要
詳細な説明
This is a single-center, randomized, double-blind, placebo-controlled, multiple-dose administration, and dose escalation phase I clinical study in adult participants aged from 18 to 45 years old (including threshold) with Healthy male and female participants.
.The multiple ascending dose (MAD) study will be conducted by increasing the dosage from low dosage level to high. Approximately 30 participants will be randomized to PG-033 or placebo in 3 dose groups.
研究の種類
入学 (推定)
段階
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Xiaohua Hao Beijing Shijitan Hospital Affiliated to Capital Medical Univer
- 電話番号:+8613466590802
- メール:xiaohualuck@sina.com
研究場所
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100038
- Beijing Shijitan Hospital, Capital Medical University
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
1. Read, understood, and signed an ICF before any investigational procedure(s) are performed..
2. Male or female aged 18 to 45 (including threshold). 3. For male participants, the body weight should be ≥ 50.0 kg, and for female paticipants, the body weight should be ≥ 45.0 kg. The body mass index (BMI) should be within the range of 19.0 to 26.0 kg/m²(including threshold) 4. Results of vital signs examination, physical examination, clinical laboratory tests (including blood routine examination, urine routine examination, blood biochemistry examination, coagulation function examination, thyroid function examination, etc.), chest X-ray, adrenal gland color ultrasound, etc. during the screening period show normal results or, if there are abnormalities, they are judged by the investigator to have no clinical significance..
5. Be willing to avoid pregnancy or voluntarily take effective contraceptive measures and have no sperm or egg donation plan from the signing of the informed consent form to three month after the last administration of the investigational medicinal product.
6. Be able to communicate well with the investigator and understand and comply with the requirements of the study.
Exclusion Criteria:
1. Participants with clinically significant abnormal electrocardiogram results judged by the investigator during screening.
2. Participants known to be allergic to this product or related excipients; or participants with an allergic constitution (such as those who are allergic to two or more drugs or foods).
3. Participants with a history of chronic diseases or severe diseases in the circulatory, urinary, respiratory, hematological and lymphatic, endocrine, immune, mental and neurological, digestive systems, etc.
4. Participants who have undergone major surgery within 6 months before the first dose administration, or those who plan to have surgery during the study period, or those who have undergone surgery that, as judged by the investigator, will affect the evaluation of the drug's safety and pharmacokinetic characteristics.
5. Participants who have used any drugs (including any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines) and health products within 2 weeks before the first dose administration.
6. Participants who have used any drugs that inhibit or induce the liver's metabolism of drugs (e.g., barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole, selective serotonin reuptake inhibitors (SSRI) antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines, etc.) within 4 weeks before the first dose administration.
7. Participants who are unable to stop consuming beverages and foods containing caffeine, alcohol, etc. (including chocolate, tea, coffee, cola, etc.), or foods that affect drug metabolism such as grapefruit, grapefruit products, pitaya, mango, pomelo, etc. from 48 hours before the first dose administration until the end of the trial, or those who are unable to stop consuming the above-mentioned diets from 48 hours before the first dose administration until the end of the trial.
8. Participants who have received live attenuated vaccine vaccination within 4 weeks before the first dose administration or those who need to receive live attenuated vaccine vaccination during the trial.
9. Participants with positive serological results for hepatitis B surface antigen (HBsAg), hepatitis C antibody, Treponema pallidum antibody, or human immunodeficiency virus antibody during screening.
10. Participants who have participated in other clinical trials within 3 months before the first dose administration.
11. Participants who have donated blood or lost a total of ≥ 400 mL of blood (excluding physiological blood loss in females) within 3 months before the first dose administration, received blood transfusion or used blood products, or those who plan to donate blood during the trial or within 1 month (30 days) after the end of the trial.
12. Participants who have consumed an average of more than 2 units of alcohol per day within 30 days before screening (1 unit ≈ 360 mL of beer or 45 mL of liquor with an alcohol content of 40% or 150 mL of wine), or those who cannot abstain from alcohol during the trial, or those with a positive result in the alcohol breath test.
13. Participants who have smoked an average of more than 5 cigarettes per day within 3 months before screening, or those who cannot stop smoking during the trial.
14. Participants with a history of drug abuse within 1 year before screening or those who tested positive for drug abuse screening.
15. Participants who cannot tolerate intravenous puncture/indwelling needle or those with a history of fainting at the sight of needles or blood.
16. Participants with special dietary requirements and who cannot accept the unified diet.
17. Pregnant or lactating women; 18. Other participants determined by the investigator to be unsuitable for participation.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ:Multiple Ascending Doses of PG-033 tablets
arm1: 20 mg each time, twice daily for 7 days; arm2: 60 mg each time, twice daily for 7 days; arm3: 90 mg each time, once daily for 7 days;
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Oral tablets (2mg, 10mg)
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プラセボコンパレーター:Placebo
arm1: 20 mg each time, twice daily for 7 days; arm2: 60 mg each time, twice daily for 7 days; arm3: 90 mg each time, once daily for 7 days;
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Oral tablets (2mg, 10mg) (matching corresponding study medication)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Safety and tolerability of PG-033 tablets
時間枠:17 days
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Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs)
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17 days
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Pharmacokinetics-Cmax
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Maximum Observed Plasma concentration (Cmax)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Tmax
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Time at which the maximum plasma concentration (Cmax) occurs
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-AUC0-t
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-AUC0-∞
時間枠:1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUC0-∞)
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1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-t1/2
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Terminal Elimination Half-Life (t1/2)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Vd/F
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Volume of Distribution (Vd/F)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-CL/F
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Total Body Clearance
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-λZ
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Elimination rate constant(λz)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-MRT
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Mean retention time (MRT)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-AUC_%Extrap
時間枠:1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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AUC Extrap/ AUC0-∞(AUC_%Extrap)
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1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Cmax,ss
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Maximum plasma concentration at steady state(Cmax,ss)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Tmax,ss
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Time to steady state Cmax(Tmax,ss)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-T1/2,ss
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Terminal Elimination Half-Life at steady state (t1/2)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-AUC 0-τ
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Area under the plasma concentration-time curve during a dosing interval (tau) at steady state (AUC 0-τ)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-AUC0-∞, ss
時間枠:1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity at steady-state (AUC0-∞)
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1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Cav,ss
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Average plasma drug concentration during a dosing interval at steady state(Cav,ss)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Cmin,ss
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,48 and 72 hours post-dose
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Minimum drug concentration at steady state(Cmin,ss)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,48 and 72 hours post-dose
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Pharmacokinetics-Vd,ss/F
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-Vd,ss/F Apparent volume of distribution at steady state after extravascular administration(Vd,ss/F)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-λz,ss
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Elimination rate constant at steady-state(λz,ss)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics-CLss/F
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Apparent plasma clearance of drug after extravascular administration at steady state(CLss/F)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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Pharmacokinetics- Rac
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,36,48 and 72 hours post-dose
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Accumulation ratio(Rac)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 ,36,48 and 72 hours post-dose
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Pharmacokinetics-DF
時間枠:D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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egree of Fluctuation(DF)
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D1:Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8 and 12 hours post-dose; D2~D6: Pre-dose; D7~D10: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 24 , 36,48 and 72 hours post-dose
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- PG-033-ND-102
- CTR20261968 (その他の識別子:https://www.chinadrugtrials.org.cn/index.html)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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