A Single-Center, Randomized, Open-Label, Three-Sequence, Three-Period, Partially Replicated Bioequivalence Study of Single-Dose ADC118 Tablets in Healthy Chinese Volunteers Under Fasting Conditions.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- PK Parameter: Cmax
研究概览
简要总结
This clinical trial aims to evaluate the bioequivalence of a single oral dose of the test drug ADC118 tablets compared with the reference drugs (ACC017 tablets and emtricitabine/tenofovir alafenamide fumarate tablets [II]) under fasting conditions in healthy adult Chinese participants. It will also assess the safety of the test drug. The main questions it aims to answer include:
Is the rate and extent of absorption of the test drug ADC118 tablets equivalent to that of the reference drugs?
What adverse events will participants experience while taking the study drugs? Researchers will compare the pharmacokinetic profiles of ADC118 tablets with those of the two reference drugs after a single dose.
Participants will:
Be randomly assigned to one of three treatment sequences (TRR, RTR, or RRT)
In each of the three periods, after an overnight fast of at least 10 hours, take a single dose of the test drug (T) or the reference drug (R) with 240 mL of warm water
Refrain from drinking water (except for the 240 mL taken with the drug) for 1 hour before and after dosing, and not eat any food for 4 hours after dosing
Complete blood sample collection and safety assessments according to the protocol This study plans to enroll 48 healthy participants. It is a single-center, randomized, open-label, three-period crossover trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males and non-pregnant, non-lactating healthy adult females, aged 18 to 55 years (inclusive) at the time of signing the informed consent form. Subjects who exceed 55 years of age during the trial will not be excluded.
- •Weight: males ≥ 50.0 kg, females ≥ 45.0 kg; body mass index (BMI) [BMI = weight (kg)/height² (m²)] between 19.0 and 26.0 kg/m² (inclusive).
- •Participants (including their partners) are willing to have no pregnancy plan from the screening period until 6 months after the end of the trial, voluntarily use effective contraceptive measures, and have no plans for childbearing or sperm/egg donation.
- •Fully understand the content of the informed consent form, voluntarily sign it, and voluntarily participate in the trial.
- •Able to complete the study according to the requirements of the trial protocol.
排除标准
- •Subjects with a history of allergy (allergic to two or more drugs or foods), or known allergy to the investigational product or its excipients.
- •Subjects with any history of clinically significant disease, or history of cardiovascular, endocrine, neurological, digestive system diseases, or pulmonary, hematological, immunological, psychiatric diseases, and metabolic abnormalities.
- •Subjects who have undergone surgery within 3 months prior to screening, or plan to undergo surgery during the trial, and those who have undergone any surgery that could affect the absorption, distribution, metabolism, or excretion of the drug.
- •Subjects with abnormalities in physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory tests that are deemed clinically significant by the investigator.
- •Female participants who are lactating or have a positive pregnancy test during the screening period or during the trial.
- •Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis screening.
- •Subjects who have taken any other investigational drug or participated in any other medical or drug clinical trial within 3 months prior to screening.
- •Subjects who have received any vaccination within 1 month prior to screening.
- •Subjects who have donated more than 400 mL of blood or experienced significant blood loss (>400 mL) within 3 months prior to screening, or who plan to donate blood during the trial or within one month after the end of the trial.
- •Subjects who have a smoking habit (average of ≥5 cigarettes per day) within 3 months prior to screening, or who are unable to abstain from using any tobacco products during the trial.
- •Subjects who have consumed more than 14 units of alcohol per week within 6 months prior to screening (1 unit of alcohol = 360 mL of beer, or 45 mL of spirits with 40% alcohol, or 150 mL of wine), or who are unable to abstain from alcohol during the trial, or who have a positive alcohol screening test.
- •Subjects with a positive drug abuse screening test, or a history of drug abuse, or who have used illicit drugs within 3 months prior to screening.
- •Subjects who have taken any prescription drugs, over-the-counter medications, health supplements, or herbal medicines within 14 days prior to screening.
- •Subjects who develop any new illness or use any new medication (including prescription drugs, over-the-counter medications, health supplements, or herbal medicines) during the period from screening to admission on Day -
- •Subjects with special dietary requirements who are unable to comply with the standardized diet.
- •Subjects with difficulty in blood collection or a history of needle phobia or vasovagal syncope associated with blood draws.
- •Subjects who are unable to complete the trial due to other reasons, or who are deemed unsuitable for enrollment by the investigator.
研究组 & 干预措施
Test-Reference-Reference Sequence
Participants assigned to this arm will receive a single oral dose of the test product (T: ADC118 tablets) in Period 1, followed by a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets [II]) in Period 2, and again the reference products (R) in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.
干预措施: ACC118-Test (Drug)
Test-Reference-Reference Sequence
Participants assigned to this arm will receive a single oral dose of the test product (T: ADC118 tablets) in Period 1, followed by a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets [II]) in Period 2, and again the reference products (R) in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.
干预措施: Reference (Drug)
Reference-Test-Reference Sequence
Participants assigned to this arm will receive a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets [II]) in Period 1, followed by a single oral dose of the test product (T: ADC118 tablets) in Period 2, and then the reference products (R) again in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.
干预措施: ACC118-Test (Drug)
Reference-Test-Reference Sequence
Participants assigned to this arm will receive a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets [II]) in Period 1, followed by a single oral dose of the test product (T: ADC118 tablets) in Period 2, and then the reference products (R) again in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.
干预措施: Reference (Drug)
Reference-Reference-Test Sequence
Participants assigned to this arm will receive a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets [II]) in Period 1, again the reference products (R) in Period 2, followed by a single oral dose of the test product (T: ADC118 tablets) in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.
干预措施: ACC118-Test (Drug)
Reference-Reference-Test Sequence
Participants assigned to this arm will receive a single oral dose of the reference products (R: ACC017 tablets co-administered with emtricitabine/tenofovir alafenamide fumarate tablets [II]) in Period 1, again the reference products (R) in Period 2, followed by a single oral dose of the test product (T: ADC118 tablets) in Period 3. All doses are administered under fasting conditions after an overnight fast of at least 10 hours, with 240 mL of warm water. A washout period separates each treatment period.
干预措施: Reference (Drug)
结局指标
主要结局
PK Parameter: Cmax
时间窗: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
Cmax is defined as the maximum observed plasma concentration of the drug, obtained directly from the concentration-time data, following a single oral dose of the test or reference product under fasting conditions.
PK Parameter: AUC0-t
时间窗: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
AUC0-t is defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable plasma concentration, calculated using the linear trapezoidal rule.
PK Parameter: AUC0-∞
时间窗: Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period
AUC0-∞ is defined as the area under the plasma concentration-time curve from time zero extrapolated to infinity, calculated as AUC0-t + Clast/λz, where Clast is the last measurable plasma concentration and λz is the terminal elimination rate constant.
次要结局
- PK Parameter: Tmax(Day 1 (pre-dose) through Day 6 (120 hours post-dose) of each treatment period)
- PK Parameter: AUC0-24h(Day 1 (pre-dose) through Day 2 (24 hours post-dose) of each treatment period)
- PK Parameter: C24h(24 hours post-dose on Day 2 of each treatment period)
- PK Parameter: AUC_%Extrap(Day 1 through Day 6 of each treatment period)
- PK Parameter: t1/2(Day 1 through Day 6 of each treatment period)
- Safety: Adverse Events(From signing of informed consent through study completion, up to approximately 10 weeks)
- Vital sign: Systolic blood pressure and diastolic blood pressure(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Vital sign: Heart rate(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Vital sign: Respiratory rate(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Vital sign: Oral body temperature(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:skin(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination: general appearance(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:head(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:eyes(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination: ears(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:oral(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:throat(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:neck(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:heart(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination:lungs(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination: extremities(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination: neuromuscular(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Physical examination: abdomen(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Clinical laboratory tests: Hematology(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Clinical laboratory tests: Blood biochemistry(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Clinical laboratory tests: Urinalysis(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- Clinical laboratory tests: Coagulation function tests(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))
- 12-Lead Electrocardiogram (ECG)(From the date of first study drug administration to the End of Study visit (defined as 6 days after last dose))