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| Name | Class |
|---|---|
| The Emmes Company, LLC | INDUSTRY |
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Multicenter, comparative single-dose pharmacokinetic (PK) study
Evaluate the pharmacokinetics of pantoprazole in obese children and adolescents with gastroesophageal reflux disease (GERD) following administration of an oral dose of pantoprazole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pantoprazole | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pantoprazole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax. | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Tmax. | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| PK Sampling | Total number of fresh plasma samples (all participants) | Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing |
| Drug Concentration in Plasma Samples | Concentration of panto in plasma and concentration of panto sulfone in plasma | Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing |
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC TBW. |
| Measure | Description | Time Frame |
|---|---|---|
| The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype | To examine the association of CYP2C19 genotype and its association with CYP2C19 phenotypes. To characterize the ability of the CYP2C19 genotype to predict pantoprazole plasma clearance, a correlation with CYP2C19 phenotype was explored using both standard linear and nonlinear regression techniques and their respective tests for significance and goodness of fit. In addition, the impact of all covariates on pantoprazole systemic exposure and apparent plasma clearance (e.g., demographic determinants of extent of obesity such as the waist:hip ratio, CYP2C19 genotype, BMI, and REE) was explored using validated population-based PK methods (NONMEM). |
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Inclusion Criteria:
Participant is between 6 and 17 (inclusive) years of age at the time of consent
BMI ≥95th percentile
Diagnosis of GERD established prior to 7 days before receipt of study drug dose defined as 1 or more of the following:
Written informed consent from the parent or legally authorized representative/guardian and participant assent per local IRB recommendation of age-appropriate consent and assent requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillip B Smith, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas | Little Rock | Arkansas | 72202 | United States | ||
| Children's Mercy Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29389444 | Derived | Shakhnovich V, Smith PB, Guptill JT, James LP, Collier DN, Wu H, Livingston CE, Zhao J, Kearns GL; Best Pharmaceuticals for Children Act - Pediatric Trials Network. Obese Children Require Lower Doses of Pantoprazole Than Nonobese Peers to Achieve Equal Systemic Drug Exposures. J Pediatr. 2018 Feb;193:102-108.e1. doi: 10.1016/j.jpeds.2017.10.011. |
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The first participant for this study began on 8-July-2014. The last participant to complete the study was on 13-September-2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pantoprazole 6-11 Year Old | The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information. |
| FG001 | Pantoprazole 12-17 Year Old | The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pantoprazole 6-11 Year Old | The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information. |
| 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 | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Cmax). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Cmax. | All participants with evaluable data. | Posted | Mean | Standard Deviation | mcg/ml | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
Adverse events were followed up to 10 days post study dose.
An AE is any untoward medical occurrence in humans, whether or not considered drug-related, which occurs during the conduct of a clinical trial. (Any change in clinical status, ECGs, routine labs, x-rays, physical examinations, etc., that is considered clinically significant by the study investigator is considered an AE.)
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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 | 6-11 Year Old Adverse Events | Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chad Livingston | Duke Clinical Research Institute | 919-668-1935 | chad.livingston@duke.edu |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000077402 | Pantoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC LBW. | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report CL/F TBW. | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F TBW. | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F LBW. | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
| 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose |
| Kansas City |
| Missouri |
| 64108 |
| United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| BG001 | Pantoprazole 12-17 Year Old | The study design included a screening visit (0-31days prior to baseline), during which informed consent was obtained and blood was collected for isolation of DNA for genotyping. During the Baseline Visit (Day 1) included REE measurement (before drug administration using a MedGem indirect calorimeter), study drug administration, and PK evaluation. The MedGem measures oxygen consumption (VO2) to determine resting metabolic rate. Study drug was then administered orally, and repeated blood samples of 1.0 ml each were collected at pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing. For those participants with the PM CYP2C19 genotype, an additional PK sample was to be obtained at 12 hours after dosing. Between Day 10 and Day 13 after the Baseline Visit, investigators conducted a follow-up call to assess participants' general wellness and to collect Adverse Event (AE) information. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Weight Percentile | Mean | Standard Deviation | percentile |
|
| Height | Mean | Standard Deviation | cm |
|
| Height Percentile | Mean | Standard Deviation | percentile |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| BMI Percentile | Mean | Standard Deviation | percentile |
|
same as participant flow wording.
|
|
| Primary | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Tmax). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Tmax. | All participants with evaluable data. | Posted | Median | Full Range | hours | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
|
|
| Primary | PK Sampling | Total number of fresh plasma samples (all participants) | All participants with evaluable data | Posted | Mean | Standard Deviation | Plasma samples | Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing | Plasma samples | Plasma samples |
|
|
|
| Primary | Drug Concentration in Plasma Samples | Concentration of panto in plasma and concentration of panto sulfone in plasma | All participants with evaluable data | Posted | Mean | Standard Deviation | ng/ml | Pre-dose (within 30 minutes), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, and 8 hours (±10 minutes) after dosing | plasma samples | plasma samples |
|
|
|
| Primary | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC TBW. | All participants with evaluable data. | Posted | Mean | Standard Deviation | mcg*h/mL | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
|
|
| Primary | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (AUC). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report AUC LBW. | All participants with evaluable data. | Posted | Mean | Standard Deviation | mcg*h/mL | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
|
|
| Primary | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (CL/F). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report CL/F TBW. | All participants with evaluable data. | Posted | Mean | Standard Deviation | l/h/kg TBW | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
|
|
| Primary | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F TBW. | All participants with evaluable data. | Posted | Mean | Standard Deviation | L/kg TBW | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
|
|
| Primary | Pharmacokinetic Analysis in Obese Children After One Single Oral Dose of Pantoprazole (Vd/F). | The pharmacokinetic blood samples will be 1.0 ml each and collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours after receiving one dose of Pantoprazole study drug. For those subjects with the poor metabolizer CYP2C19 genotype, an additional PK sample will be obtained at 12 hours after dosing. Here we report Vd/F LBW. | All participants with evaluable data. | Posted | Mean | Standard Deviation | L/kg LBW | pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, & 8 hours |
|
|
|
| Secondary | The CYP2C19 Genotype and Its Association With CYP2C19 Phenotype | To examine the association of CYP2C19 genotype and its association with CYP2C19 phenotypes. To characterize the ability of the CYP2C19 genotype to predict pantoprazole plasma clearance, a correlation with CYP2C19 phenotype was explored using both standard linear and nonlinear regression techniques and their respective tests for significance and goodness of fit. In addition, the impact of all covariates on pantoprazole systemic exposure and apparent plasma clearance (e.g., demographic determinants of extent of obesity such as the waist:hip ratio, CYP2C19 genotype, BMI, and REE) was explored using validated population-based PK methods (NONMEM). | Total analyzed #participants is 38. Total #participants in age groups is 37 excluding one poor-metabolizer. Poor metabolizer is defined as a participant who had *2/*2 alleles; intermediate metabolizer is defined as a participant who had *1/*2 or *2/*17 alleles; extensive metabolizer is defined as a participant who had *1/*1 or *1/*17 alleles. | Posted | Median | Full Range | L/h | 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 1 |
| 19 |
| EG001 | 12-17 Year Old Adverse Events | Study participants were selected from obese children and adolescents ranging in age from 6 17 years (inclusive) and seen in the outpatient clinic for the diagnosis or treatment of GERD. The target enrollment was 40 participants (20 participants 6-11 years of age and up to 20 participants 12 17 years of age). Potential study participants could come from any outpatient clinical setting within participating institutions where children with GERD were seen for evaluation and/or treatment. | 0 | 22 | 0 | 22 | 6 | 22 |
| Pyrexia | General disorders | MedRA | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedRA | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedRA | Systematic Assessment |
|
| nephrolithiasis | Renal and urinary disorders | MedRA | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedRA | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment |
|
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| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|
| Pantoprazole Sulfone |
|
|