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| ID | Type | Description | Link |
|---|---|---|---|
| JapicCTI-163471 | Other Identifier | Japic |
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To assess the bioequivalence of OPC-41061 OD tablets and OPC-41061 conventional tablets at 15 and 30 mg in healthy adult male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPC41061(15 mg) disintegrating tablet with water | Experimental | OPC41061 (15 mg) orally disintegrating tablet is administered with water. |
|
| OPC-41061(15 mg) disintegrating tablet without water | Experimental | OPC41061 (15 mg) orally disintegrating tablet is administered without water. |
|
| OPC-41061(15 mg) conventional tablet with water | Experimental | OPC-41061 (15 mg) conventional tablet is administered with water. |
|
| OPC41061(30 mg) disintegrating tablet with water | Experimental | OPC41061 (30 mg) orally disintegrating tablet is administered with water. |
|
| OPC-41061(30 mg) disintegrating tablet without water | Experimental | OPC41061 (30 mg) orally disintegrating tablet is administered without water. |
|
| OPC-41061(30 mg) conventional tablet with water |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPC-41061 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Tolvaptan | Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation. | Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose |
| Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan | Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation. | Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroaki Ono, Mr | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu Region | Japan |
A total of 84 subjects were divided into 2 cohorts of 42 subjects each. The 42 subjects each in 2 cohorts were randomly assigned to the conventional tablet first group, OD tablet with water first group, or OD tablet without water first group according to the randomization code in a 1:1:1 ratio. Forty subjects in Cohort 1 and 41 subjects in Cohort 2 completed the trial.
This single-center, open-label, randomized, 3-period 3-way, crossover study using 2 different formulations and 2 different dosing regimens investigated bioequivalence between tolvaptan orally disintegrating (OD) and conventional tablets in 84 healthy adult male subjects in 2 cohorts. Bioequivalence between the OD and conventional 15 mg tablets was investigated in Cohort 1. In Cohort 2, bioequivalence between the OD and conventional 30 mg tablets was investigated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Conventional Tablet, Then OD Tablet Without Water, Then OD Tablet With Water | Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| FG001 | Cohort 1: OD Tablet With Water, Then Conventional Tablet, Then OD Tablet Without Water | Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| FG002 | Cohort 1: OD Tablet Without Water, Then OD Tablet With Water, Then Conventional Tablet | Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| FG003 | Cohort 2: Conventional Tablet, Then OD Tablet Without Water, Then OD Tablet With Water | Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| FG004 | Cohort 2: OD Tablet With Water, Then Conventional Tablet, Then OD Tablet Without Water | Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| FG005 | Cohort 2: OD Tablet Without Water, Then OD Tablet With Water, Then Conventional Tablet | Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Days 1 to 3) |
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| Period 2 (Days 4 to 6) |
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| Period 3 (Days 7 and 8) |
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Safety analysis set: all subjects that received at least 1 dose of investigational medicinal product (IMP).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Subjects received single oral administration of tolvaptan 15 mg in Cohort 1, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) of Tolvaptan | Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation. | Bioequivalence analysis set: all subjects with both AUCt and Cmax values across Period 1, Period 2, and Period 3. | Posted | Mean | Standard Deviation | ng/mL | Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose |
|
Treatment-emergent adverse events were collected during the treatment period (8 days)
Safety analysis set: all subjects that received at least 1 dose of IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: 15 mg Conventional Tablet | Single oral administration of 1 tolvaptan 15 mg conventional tablet with water under fasting conditions |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 25, 2016 | May 10, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2017 | May 10, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077602 | Tolvaptan |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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OPC-41061 (30 mg) conventional tablet is administered with water. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| BG001 |
| Cohort 2 |
Subjects received single oral administration of tolvaptan 30 mg in Cohort 2, conventional or OD tablet, with or without water on each administration day in Period 1, Period 2, and Period 3. A washout period of 72 hours was set from postdose in Period 1 until predose in Period 2 and from postdose in Period 2 until predose in Period 3. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Single oral administration of 1 tolvaptan 15 mg OD tablet without water under fasting conditions
| OG002 | Cohort 1: 15 mg OD Tablet With Water | Single oral administration of 1 tolvaptan 15 mg OD tablet with water under fasting conditions |
| OG003 | Cohort 2: 30 mg Conventional Tablet | Single oral administration of 1 tolvaptan 30 mg conventional tablet with water under fasting conditions |
| OG004 | Cohort 2: 30 mg OD Tablet Without Water | Single oral administration of 1 tolvaptan 30 mg OD tablet without water under fasting conditions |
| OG005 | Cohort 2: 30 mg OD Tablet With Water | Single oral administration of 1 tolvaptan 30 mg OD tablet with water under fasting conditions |
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Observable Concentration at Time t (AUCt) of of Tolvaptan | Blood sampling for plasma tolvaptan concentration before IMP administration and 1, 2, 3, 4, 5, 6, 8, 10, 12, and 16 hours postdose in each period in Cohort 1 and 2 was performed for pharmacokinetic evaluation. | Bioequivalence analysis set: all subjects with both AUCt and Cmax values across Period 1, Period 2, and Period 3. | Posted | Mean | Standard Deviation | ng*h/mL | Pre-dose and 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 hours post-dose |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 1 |
| 41 |
| EG001 | Cohort 1: 15 mg OD Tablet Without Water | Single oral administration of 1 tolvaptan 15 mg OD tablet without water under fasting conditions | 0 | 41 | 0 | 41 | 1 | 41 |
| EG002 | Cohort 1: 15 mg OD Tablet With Water | Single oral administration of 1 tolvaptan 15 mg OD tablet with water under fasting conditions | 0 | 41 | 0 | 41 | 2 | 41 |
| EG003 | Cohort 2: 30 mg Conventional Tablet | Single oral administration of 1 tolvaptan 30 mg conventional tablet with water under fasting conditions | 0 | 42 | 0 | 42 | 1 | 42 |
| EG004 | Cohort 2: 30 mg OD Tablet Without Water | Single oral administration of 1 tolvaptan 30 mg OD tablet without water under fasting conditions | 0 | 42 | 0 | 42 | 0 | 42 |
| EG005 | Cohort 2: 30 mg OD Tablet With Water | Single oral administration of 1 tolvaptan 30 mg OD tablet with water under fasting conditions | 0 | 41 | 0 | 41 | 0 | 41 |
| Vomiting | Gastrointestinal disorders | MedDRA Ver. 20.0 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA Ver. 20.0 | Non-systematic Assessment |
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