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The purpose of this study is to compare the pharmacodynamics/pharmacokinetics of 5 mg, 10 mg, 20 mg and 40 mg of Rabeprazole sodium (E3810) when administered repeatedly once daily for 5 days to healthy adult male Japanese participants. This was a single-center, open-label, randomized, four-treatment, four-way crossover study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rabeprazole sodium Tablets, 5 mg | Experimental |
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| Rabeprazole sodium Tablets, 10 mg | Experimental |
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| Rabeprazole sodium Tablets, 20 mg | Experimental |
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| Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rabeprazole sodium, 5 mg Tablets | Drug | Rabeprazole sodium Tablets, 5 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration | The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. | Day 5 of administration during Period I-IV |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) | Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masahiro Munesue | Japan/Asia Clinical Research Product Creation Unit, Japan Clinical Development, Japan Clinical Development Section | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toshima-ku | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22108775 | Derived | Hayato S, Hasegawa S, Hojo S, Okawa H, Abe H, Sugisaki N, Munesue M, Horai Y, Ohnishi A. Dose-response relationships of rabeprazole 5, 10, 20, and 40 mg once daily on suppression of gastric acid secretion through the night in healthy Japanese individuals with different CYP2C19 genotypes. Eur J Clin Pharmacol. 2012 May;68(5):579-88. doi: 10.1007/s00228-011-1164-7. Epub 2011 Nov 23. |
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This study was recruited at 1 center in Japan during the period of 14-Sep-2010 to 2-Dec-2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg Each Period was separated by a >= 6 day washout period. Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Rabeprazole sodium, 10 mg Tablets | Drug | Rabeprazole sodium Tablets, 10 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast. |
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| Rabeprazole sodium, 20 mg Tablets | Drug | Rabeprazole sodium Tablets, 20 mg administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast. |
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| Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets) | Drug | Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days. Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer. Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast. |
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| Day 1 and Day 5 of administration during Period I-IV |
| Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t]) | Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. | Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose) |
| FG001 | Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg Each Period was separated by a >= 6 day washout period. Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge. |
| FG002 | Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg Each Period was separated by a >= 6 day washout period. Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge. |
| FG003 | Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg Each Period was separated by a >= 6 day washout period. Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population: Group A, Group B, Group C, Group D | Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period. Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Baseline Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours on Day 1 | The 24-hour intragastric pH monitoring was performed before the start of administration in Period I. Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. | Mean | Standard Deviation | Percentage of Time in a 24 Hour Period |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Percentage Duration With An Intragastric pH >= 4 During The Entire 24 Hours Of Day 5 Administration | The 24-hour intragastric pH monitoring was performed on Day 5 of administration in each study period (Period I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. | Posted | Mean | Standard Deviation | Percentage of Time in a 24 Hour Period | Day 5 of administration during Period I-IV |
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| Secondary | Pharmacokinetic Parameter: Maximal Drug Concentration (Cmax) | Pharmacokinetic parameter: maximal drug concentration (Cmax) measured in nanograms per milliliter (ng/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. | Posted | Mean | Standard Deviation | ng/mL | Day 1 and Day 5 of administration during Period I-IV |
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| Secondary | Pharmacokinetic Parameter: Area Under the Plasma Concentration-Time Curve From Time 0 to Time t (AUC[0-t]) | Pharmacokinetic parameter: Area under the plasma concentration-time curve from time 0 (administration of the drug) to time t (the last quantifiable concentration time point). AUC measured in nanogram hours per milliliter (ng*h/mL) was calculated on Day 1 and Day 5 of administration during each Period (I-IV). Data was displayed based on the participant's CYP2C19 genotype: CYP2C19-EM are extensive metabolizers who have normal metabolizing capacity. CYP2C19-PM are poor metabolizers with a metabolizing capacity deficiency or remarkably decreased metabolizing capacity. | Posted | Mean | Standard Deviation | ng*h/mL | Day 1 and Day 5 of administration during Period I-IV (0, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 8, 10, 12, 24 hours post-dose) |
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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 | Rabeprazole Sodium 5 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 5 mg was received by: Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II | 0 | 24 | 0 | 24 | ||
| EG001 | Rabeprazole Sodium 10 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 10 mg was received by: Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III | 0 | 24 | 0 | 24 | ||
| EG002 | Rabeprazole Sodium 20 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 20 mg was received by: Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV | 0 | 24 | 0 | 24 | ||
| EG003 | Rabeprazole Sodium 40 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 40 mg was received by: Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I | 0 | 24 | 0 | 24 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Masaharu Yokoyama, Director | Eisai Co., Ltd. | +81-3-3817-3908 | m-yokoyama@hhc.eisai.co.jp |
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Title | Measurements |
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| CYP2C19 Poor Metabolizers 'PM' (n=8) |
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Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 20 mg was received by: Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV |
| OG003 | Rabeprazole Sodium 40 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 40 mg was received by: Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I |
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| OG002 | Rabeprazole Sodium 20 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 20 mg was received by: Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV |
| OG003 | Rabeprazole Sodium 40 mg Tablet | Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period. Rabeprazole sodium 40 mg was received by: Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I |
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