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A two-phase study design will be used for this pilot study. In the first phase, a 2×2 crossover study will be used to evaluate the safety, tolerability and PK characteristic of APL-1202 and APL-1501 ER Tablets 3. Twelve healthy subjects will be in ratio 1:1 randomly assigned to two groups, randomization will be stratified by gender (male, female) in ratio 1:1. Each group will be dosed with APL-1202, APL-1501 ER Tablets 3 in a cross-over way. A 7-day (±1 day) washout will be required before next period of drug administration. The samples in first phase will be sent to bioanalysis lab for PK research at the end of first phase. The initiate of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2 | Drug | Phase1: Period 1 drug administration( APL-1202 50 mg, 3 tablets, orally );Washout( 7± 1 day) ; Period 2 drug administration(1501 ER Tablets 3 382 mg ASN-1324, 1 tablet); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet) |
| Measure | Description | Time Frame |
|---|---|---|
| AEs | Number of subjects with AEs, | 6 months |
| SAEs | Number of subjects with SAEs | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters: area under the curve (AUC) | Area under the curve (AUC) of APL-1501 ER Tablets, and APL-1202 Tablets | 6 months |
| PK parameters: maximum concentration (Cmax) | maximum concentration (Cmax), of APL-1501 ER Tablets, and APL-1202 Tablets |
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Inclusion Criteria:
The subject must have informed consent before the trial, and have a full understanding of the content, process and possible adverse reactions of the trial, and voluntarily signed a written informed consent form
The subject is able to communicate well with the researchers and is able to complete the trial in accordance with the protocol
18 to 45 years old (including 18 and 45 years old)
Postmenopausal females or sterilized participant must be at least 6 months post-menopausal, surgically sterile; the postmenopausal/sterilization should be confirmed by FSH testing
The body weight of male subjects are ≥ 50 kg, and that of female subjects are ≥ 45 kg, and the body mass index (BMI) are between 18.0 and 30.0 kg/m2, including the boundary value. BMI= weight (kg) / height2 (m2)
Must have normal organ functions, including the following:
Healthy as determined by physician, based on a medical evaluation including Physical examination and vital signs, hematology, biochemistry, coagulation, urinalysis, and 12-lead Electrocardiograms (ECGs)
Willingness for subjects of reproductive potential to use highly effective methods of contraception from the beginning of the study screening to the end of study follow up period a. A highly effective method of contraception is defined as one that results in a low failure rate (i.e., less than 1% per year, when used consistently and correctly)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia clinical research | Randwick | New South Wales | 2031 | Australia |
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|
| APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2 | Drug | Phase1: Period 1 drug administration( 1501 ER Tablets 3 382 mg ASN-1324, 1 tablet );Washout( 7± 1 day) ; Period 2 drug administration(APL-1202 50 mg, 3 tablets, orally); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet) |
|
| 6 months |
| PK parameters: Tmax | Tmax of APL-1501 ER Tablets, and APL-1202 Tablets | 6 months |
| PK parameters: half-life | apparent t1/2 of APL-1501 ER Tablets, and APL-1202 Tablets | 6 months |
| Urine concentration | Urine concentration of APL-1501 ER Tablets 2, APL-1501 ER Tablets 3, and APL-1202 Tablets. | 6 months |
| Accumulated excretion rate (Ae%) | Accumulated excretion rate (Ae%) of APL-1501 ER Tablets 2, APL-1501 ER Tablets 3, and APL-1202 Tablets. | 6 months |
| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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