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The purpose of this study is to investigate the impact of SHR20004 on the pharmacokinetic (PK) characteristics of acetaminophen in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen+SHR20004 | Experimental |
| |
| Acetaminophen+Placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen/SHR20004 | Drug | SHR20004 was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.:(AUC0-300min) | Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min) | Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 | |
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (AUC0-60min/AUC0-300min) |
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Inclusion Criteria:
Exclusion Criteria:
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1. Subjects with any of the following conditions or medical history:
2. Use of prescription drugs (topical eye/ nasal drops and ointments are allowed) and over-the-counter drugs, food supplements, vitamins, and Chinese herbs within 2 weeks before the start of treatment (routine vitamins are allowed).
3. Any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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This study is a single-center, randomized, double-blind, placebo-controlled, crossover study. Healthy subjects were randomly assigned to receive SHR20004 or placebo treatment. In the group receiving SHR20004, the pharmacokinetic changes of acetaminophen were compared before and after treatment with SHR20004.
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| Acetaminophen/Placebo | Drug | Placebo was administered by titration, with all subjects starting on Day 4 with an initial dose of 0.03 mg/d of SHR20004 or placebo, with the dose being increased by 0.03 mg/d per week. The dose was increased to 0.15 mg/d and then maintained for 5 days. |
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| Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 |
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Cmax) | Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 |
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Tmax) | Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 |
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (t1/2) | Based on pre-dose to min post-dose sampling times on Day 1 and Day 31 |
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (CL/F) | Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 |
| Pharmacokinetics parameters of acetaminophen after a single dose of 1.0 g was measured after administration of the standardized meal.: (Vz/F) | Based on pre-dose to 300 min post-dose sampling times on Day 1 and Day 31 |
| Incidence and severity of AE/SAE/AESI. | Screening period up to Day 50 |
| Electrocardiographic parameters Fridericia-corrected QT interval (QTcF) | Mean QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings. | Day 1 and Day 10 and Day 30 and Day 36 |
| Delta QTcF | Mean change from baseline in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake. | Day 1 and Day 10 and Day 30 and Day 36 |
| Double-delta QTcF (ΔΔQTcF) | Mean change from baseline and placebo in QTcF as measured based on triplicate electrocardiograms extracted from continuous 12-lead Holter monitor recordings after study drug intake. | Day 1 and Day 10 and Day 30 and Day 36 |
| Concentration-delta QTcF Correlation | Correlation between SHR20004 plasma concentration and delta QTcF based on appropriate regression model. | Day 1 and Day 10 and Day 30 and Day 36 |
| Concentration-double-delta QTcF Correlation | Correlation between SHR20004 plasma concentration and double-delta QTcF based on appropriate regression model. | Day 1 and Day 10 and Day 30 and Day 36 |
| Immunogenicity indicators: anti-Noiiglutide antibodies | Start of treatment up to Day 50 |
| D004700 | Endocrine System Diseases |
| Aniline Compounds |
| D000588 | Amines |