NCT06678542
已完成
1 期
A Phase 1, Open-label, Single-site, Randomized, Single-dose, Two-Period, Crossover Study to Assess the Relative Bioavailability of GP681 Powder for Oral Suspension and Tablet Formulations in Healthy Chinese Male Subjects
概览
- 阶段
- 1 期
- 干预措施
- GP681 tablet
- 疾病 / 适应症
- Healthy Participants
- 发起方
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
The primary objective is to evaluate the relative bioavailability and pharmacokinetic profile of a single oral dose of the test formulation, GP681 Powder for Oral Suspension (20 mg/sachet), compared to the reference formulation, GP681 tablet (20 mg/tablet), in healthy Chinese male subjects. The secondary objectives are to assess the safety of a single oral dose of the GP681 Powder for Oral Suspension (20 mg/sachet) and GP681 tablet (20 mg/tablet) in healthy Chinese male subjects, as well as the palatability (taste acceptability) of the GP681 Powder for Oral Suspension.
研究者
入排标准
入选标准
- •Gender: Healthy male subjects.
- •Age: 18 to 45 years (inclusive).
- •Body Weight: Body mass index (BMI = weight (kg)/height2 (m2)) between 19.0 and 26.0 kg/m2 (inclusive), with body weight ≥ 50.0 kg.
- •Taste Perception Ability: Successfully passed the taste perception ability test.
- •Informed Consent: Fully understands the study's purpose, nature, requirements, methodology, and potential adverse reactions; voluntarily agrees to participate in the clinical trial and signs the informed consent form prior to any study procedures.
- •Contraception: Subject (and their partner) has no plans to conceive or donate sperm from the time of first dosing until 3 months after the last dose and agrees to use effective contraception during this period.
排除标准
- •Clinically significant abnormalities, as determined by the investigator, including history of neurological, respiratory, cardiovascular, gastrointestinal, urinary, hematological and lymphatic, endocrine, musculoskeletal, or other disorders that could affect study results, or history of gastrointestinal disease within 3 months prior to screening.
- •Inability to accurately express true taste perception.
- •Dysfunction in taste or olfactory senses.
- •Known hypersensitivity or allergy to the investigational product or any of its components (e.g., copovidone, crospovidone, lactose, microcrystalline cellulose, mannitol, maltitol, hydroxypropyl methylcellulose, colloidal silicon dioxide, sodium stearyl fumarate, sucralose, strawberry flavoring), or history of allergic diseases or a predisposition to allergies.
- •Clinically significant abnormalities in vital signs, physical examination, clinical laboratory tests, 12-lead ECG, or chest X-ray (posteroanterior view), or QTcF \>450 ms, as assessed by the investigator.
- •Positive test results for hepatitis B surface antigen (HBsAg), HCV antibodies, Treponema pallidum antibodies, or HIV antibodies.
- •Smoking ≥10 cigarettes per day within 3 months prior to the first dose.
- •Surgical procedure within 3 months before the first dose or planned surgery during the study period.
- •Blood donation or significant blood loss ≥400 mL within 3 months before the first dose, or plans to donate blood within 3 months after the study.
- •Participation in another clinical drug trial within 3 months before the first dose.
研究组 & 干预措施
Treatment sequence T-R
干预措施: GP681 tablet
Treatment sequence T-R
干预措施: GP681 Powder for Oral Suspension
Treatment sequence R-T
干预措施: GP681 tablet
Treatment sequence R-T
干预措施: GP681 Powder for Oral Suspension
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration[AUC(0-T)]
时间窗: Up to 360 hours post-dose
Area under the plasma concentration-time curve from time zero extrapolated to infinite time[AUC(INF)]
时间窗: Up to 360 hours post-dose
次要结局
- Time of maximum observed concentration(Tmax)(Up to 360 hours post-dose)
- Apparent terminal half-life (T-HALF)(Up to 360 hours post-dose)
- Incidence of adverse events (AEs)(Up to approximately 1 month post-dose)
- Incidence of serious adverse events (SAEs)(Up to approximately 1 month post-dose)
- Incidence of participants with vital sign abnormalities(Up to approximately 1 month post-dose)
- Incidence of participants with physical examinations abnormalities(Up to approximately 1 month post-dose)
- Incidence of participants with electrocardiogram (ECG) abnormalities(Up to approximately 1 month post-dose)
- Incidence of participants with clinical laboratory abnormalities(Up to approximately 1 month post-dose)
- Palatability Evaluation(Up to 24 hours post-dose)
研究点 (1)
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