Gastroesophageal Reflux Disease
Conditions
Keywords
candidate for acid suppression therapy, presumptive diagnosis of GERD, clinical diagnosis of suspected GERD, symptomatic GERD, endoscopically proven GERD
Brief summary
The purpose of this study is to characterize the pharmacokinetics (PK) and safety of intravenous (IV) pantoprazole in patients 1 to 16 years old who are candidates for acid suppression therapy.
Detailed description
In hospitalized pediatric subjects, age 1 to 16 years who in the judgment of the investigator are candidates for acid suppression therapy, the following are the objectives of this trial: Primary Objectives To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 1 to less than 2 years old. To characterize the PK of single and multiple IV doses of pantoprazole in pediatric subjects aged 2 to 16 years old. Secondary Objectives To determine the safety, tolerability, and PK of single and multiple IV doses of pantoprazole in each of the independent age cohorts. To assess the CYP2C19 genotype in pediatric subjects receiving IV pantoprazole, to determine the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.
Interventions
DRUGIV pantoprazole
Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight
Sponsors
Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Subjects aged 1 to 16 years who in the judgment of the investigator are candidates for gastric acid suppression therapy (ie, those with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD) and whom the investigator judges would need to receive IV PPI therapy for at least 4 days. * Body weight \> 5th percentile for age. * Y-site or dedicated IV line for administration of pantoprazole sodium. * Expected survival for at least 30 days. * Fertile male and female subjects of childbearing potential at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. Female subjects of non-childbearing potential must be premenarchal, have undergone hysterectomy with bilateral oophorectomy, have medically confirmed ovarian failure, or achieved post-menopausal status.
Exclusion criteria
* Participation in other studies involving investigational drug(s) or treatment with an investigational drug within 30 days or 5 half lives prior to study entry and/or during study participation. * Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. * Pregnant females; breastfeeding females; fertile male subjects, and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 28 days after last dose of investigational product. * Serum CK levels \>3x ULN. * Known history of HIV or clinical manifestations of AIDS. * Known hypersensitivity to PPIs or to any substituted benzimidazole or to any of the excipients. * History of treatment with any PPI within 2 days (48 hours) before investigational product dosing on Day 1. * Use of H2RAs, sucralfate, misoprostol, or prokinetic agents, and bismuth preparations within 1 day (24 hours) before investigational product dosing on Day 1. * Any disorder requiring chronic (every day) use of warfarin, carbamazepine, or phenytoin, methotrexate, atazanavir or nelfinavir, clopidogrel, and potent inhibitors and inducers of CYP2C19. * Chronic (daily) use of glucocorticoids. Steroid inhalers and topical steroids may be used. * Active malignancy of any type, or history of a malignancy (Subject with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable). * ALT or BUN \>2.0 ULN or estimated creatinine \>1.5 X ULN for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before Screening. * In the Investigator's opinion, a chronic condition (eg, diabetes, epilepsy), which is either not stable or well controlled and may interfere with the conduct of the study. * History of sensitivity to heparin or heparin induced thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance (CL) of Pantoprazole | 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7 | Data reported below is combined for Days 1, 2 and 7. |
| Volume of Distribution (Vd) of Pantoprazole | 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7 | Data reported below is combined for Days 1, 2 and 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose | 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2) | The results for AUC24 were presented separately for single dose and multiple doses. |
| Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose | 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7 | Data reported below is combined for Days 2 and 7. |
| Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose | 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1 | The results for AUCinf were presented separately for single dose and multiple doses. |
| Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose | 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7 | Data reported below is combined for Days 2 and 7. |
| Terminal Half-Life (t1/2) of Pantoprazole | 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7 | Data reported below is combined for Days 1, 2 and 7. |
| Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose | 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1 | The results for Cmax were presented separately for single dose and multiple doses. |
| Number of Participants With Adverse Events (AEs) | From Day 1 up to 34 days after the last dose (maximum up to 41 days) | An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product; the event need not necessarily had a causal relationship with the treatment or usage. |
| Number of Participants With Laboratory Abnormalities of Potential Clinical Concern | Up to Day 9 | Number of participants with abnormalities in laboratory parameters of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator. |
| Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern | At screening (Day 0) | Number of participants with abnormalities in physical examination of potential concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator. |
| Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern | Up to Day 9 | Number of participants with abnormalities in blood pressure of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator. |
| Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern | Up to Day 9 | Number of participants with abnormalities in pulse rate of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator. |
| Number of Participants According to CYP2C19 Genotyping | Day 1 | CYP2C19 genotype was assessed in pediatric participants who received intravenous pantoprazole sodium and determined the presence of the gene for the major enzyme responsible for metabolism of pantoprazole. |
| Cmax of Pantoprazole: Multiple Dose | 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7 | Data reported below is combined for Days 2 and 7. |
Countries
Argentina, Bosnia and Herzegovina, Georgia, Germany, Italy, Serbia, Slovakia, Ukraine, United States
Participant flow
Pre-assignment details
A total of 19 participants were enrolled. Nineteen participants were randomized and assigned to a study treatment out of which, 1 participant was not randomized to any study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (>=1 to < 2 Years) Participants aged \>= 1 year to \< 2 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning. | 3 |
| Cohort 2 (>=2 to <16 Years) Participants aged \>= 2 to \< 16 years received intravenous pantoprazole sodium as per body weight with maximum dose not exceeded 40 mg, once daily for 4 to 7 days, approximately every 24-hours, preferred in the morning. | 16 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Cohort 2 (>=2 to <16 Years) | Total | Cohort 1 (>=1 to < 2 Years) |
|---|---|---|---|
| Age, Continuous | 9.31 Years STANDARD_DEVIATION 4.729 | 8.00 Years STANDARD_DEVIATION 5.323 | 1.00 Years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 19 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 19 Participants | 3 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 0 Participants |
| Sex: Female, Male Male | 9 Participants | 12 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 16 |
| other Total, other adverse events | 0 / 2 | 8 / 16 |
| serious Total, serious adverse events | 0 / 2 | 1 / 16 |
Outcome results
Primary
Clearance (CL) of Pantoprazole
Data reported below is combined for Days 1, 2 and 7.
Time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Population: The pharmacokinetic (PK) parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Clearance (CL) of Pantoprazole | 1.930 Liter per hour | Geometric Coefficient of Variation 82 |
| Cohort 2 (>=2 to <16 Years) | Clearance (CL) of Pantoprazole | 4.739 Liter per hour | Geometric Coefficient of Variation 71 |
Primary
Volume of Distribution (Vd) of Pantoprazole
Data reported below is combined for Days 1, 2 and 7.
Time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Volume of Distribution (Vd) of Pantoprazole | 1.622 Liter | Geometric Coefficient of Variation 58 |
| Cohort 2 (>=2 to <16 Years) | Volume of Distribution (Vd) of Pantoprazole | 5.584 Liter | Geometric Coefficient of Variation 74 |
Secondary
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose
Data reported below is combined for Days 2 and 7.
Time frame: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose | 5708 ng*hr/mL | Geometric Coefficient of Variation 82 |
| Cohort 2 (>=2 to <16 Years) | Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Multiple Dose | 6707 ng*hr/mL | Geometric Coefficient of Variation 61 |
Secondary
Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose
The results for AUCinf were presented separately for single dose and multiple doses.
Time frame: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose | 6022 ng*hr/mL | Geometric Coefficient of Variation 84 |
| Cohort 2 (>=2 to <16 Years) | Area Under the Plasma Concentration-time Profile From Time Zero Extrapolated to Infinite Time (AUCinf) of Pantoprazole: Single Dose | 6542 ng*hr/mL | Geometric Coefficient of Variation 62 |
Secondary
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose
Data reported below is combined for Days 2 and 7.
Time frame: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Since dosing interval between 2 doses are 24 hours, individual post-hoc estimated AUC from population PK analysis is AUC24. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose | 5705 ng*hr/mL | Geometric Coefficient of Variation 82 |
| Cohort 2 (>=2 to <16 Years) | Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Multiple Dose | 6690 ng*hr/mL | Geometric Coefficient of Variation 60 |
Secondary
Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose
The results for AUC24 were presented separately for single dose and multiple doses.
Time frame: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 24 hours post dose on Day 1 (pre dose on Day 2)
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose | 6022 Nanogram* hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 84 |
| Cohort 2 (>=2 to <16 Years) | Area Under the Plasma Concentration-time Profile From Time Zero to 24 Hour (AUC24) of Pantoprazole: Single Dose | 6533 Nanogram* hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 62 |
Secondary
Cmax of Pantoprazole: Multiple Dose
Data reported below is combined for Days 2 and 7.
Time frame: 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post dose on Day 7
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest. Here, ''Overall Number of Participants Analyzed'' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Cmax of Pantoprazole: Multiple Dose | 5259 ng/mL | Geometric Coefficient of Variation 60 |
| Cohort 2 (>=2 to <16 Years) | Cmax of Pantoprazole: Multiple Dose | 4423 ng/mL | Geometric Coefficient of Variation 47 |
Secondary
Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose
The results for Cmax were presented separately for single dose and multiple doses.
Time frame: 0.25, 1, 2, 3 to 4, and 5 to 6 hours post-dose on Day 1
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose | 5259 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 60 |
| Cohort 2 (>=2 to <16 Years) | Maximum Plasma Concentration (Cmax) of Pantoprazole: Single Dose | 4280 Nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 48 |
Secondary
Number of Participants According to CYP2C19 Genotyping
CYP2C19 genotype was assessed in pediatric participants who received intravenous pantoprazole sodium and determined the presence of the gene for the major enzyme responsible for metabolism of pantoprazole.
Time frame: Day 1
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Number of Participants According to CYP2C19 Genotyping | 0 Participants |
| Cohort 2 (>=2 to <16 Years) | Number of Participants According to CYP2C19 Genotyping | 0 Participants |
Secondary
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product; the event need not necessarily had a causal relationship with the treatment or usage.
Time frame: From Day 1 up to 34 days after the last dose (maximum up to 41 days)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Number of Participants With Adverse Events (AEs) | 0 Participants |
| Cohort 2 (>=2 to <16 Years) | Number of Participants With Adverse Events (AEs) | 8 Participants |
Secondary
Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in blood pressure of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Time frame: Up to Day 9
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern | 0 Participants |
| Cohort 2 (>=2 to <16 Years) | Number of Participants With Blood Pressure Abnormalities of Potential Clinical Concern | 0 Participants |
Secondary
Number of Participants With Laboratory Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in laboratory parameters of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Time frame: Up to Day 9
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Number of Participants With Laboratory Abnormalities of Potential Clinical Concern | 0 Participants |
| Cohort 2 (>=2 to <16 Years) | Number of Participants With Laboratory Abnormalities of Potential Clinical Concern | 0 Participants |
Secondary
Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in physical examination of potential concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Time frame: At screening (Day 0)
Population: Safety analysis set included all participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern | 0 Participants |
| Cohort 2 (>=2 to <16 Years) | Number of Participants With Physical Examination Abnormalities of Potential Clinical Concern | 0 Participants |
Secondary
Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern
Number of participants with abnormalities in pulse rate of potential clinical concern were reported in this outcome measure. The criteria to determine the abnormalities was determined by the investigator.
Time frame: Up to Day 9
Population: Safety analysis set included all the participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern | 0 Participants |
| Cohort 2 (>=2 to <16 Years) | Number of Participants With Pulse Rate Abnormalities of Potential Clinical Concern | 0 Participants |
Secondary
Terminal Half-Life (t1/2) of Pantoprazole
Data reported below is combined for Days 1, 2 and 7.
Time frame: 0.25, 1 to 2, 3 to 4, and 5 to 6 hours post-dose on Day 1; 0.25, 0.5, 1 to 2, 3 to 4, and 5 to 6, 8, and 12 hours post-dose on Day 2; 0.25, 0.5, 1, 2, 4, 8, and 12 hours post-dose on Day 7
Population: The PK parameter analysis population included all participants treated with pantoprazole who had at least 1 of the PK parameters of primary interest.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (>=1 to < 2 Years) | Terminal Half-Life (t1/2) of Pantoprazole | 2.805 Hours | Standard Deviation 0.1909 |
| Cohort 2 (>=2 to <16 Years) | Terminal Half-Life (t1/2) of Pantoprazole | 3.767 Hours | Standard Deviation 0.6802 |