Healthy
Conditions
Keywords
Bioequivalence, Healthy Subjects
Brief summary
The object of this study is to compare the relative bioavailability of lansoprazole 30 mg delayed-release capsules (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PREVACID® capsules (TAP Pharmaceuticals, Inc.) in healthy, adult, subjects under fasting conditions with dosing by applesauce-sprinkle method.
Detailed description
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Interventions
DRUGLansoprazole
30 mg Delayed-Release Capsules
DRUGPrevacid®
30 mg Delayed-Release Capsule
Sponsors
Teva Pharmaceuticals USA
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Non-smokers or light smokers (10 or less cigarettes per day) * 18 years of age or older * Body Mass Index of 30 or less * Males or non-pregnant females * Normal clinical laboratory test results
Exclusion criteria
* Subjects with a significant history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, or cardiovascular disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for the study. * Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant. * Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study. * Subjects who are heavy users of tobacco (smoke more than 10 cigarettes a day, smoke cigars or pipes, or use oral tobacco products) will not be eligible to participate in the study. Light smokers may participate, but can not smoke from 2 hours before dosing until 2 hours after dosing. * Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate. * Subjects who have taken any investigational drug within 30 days prior to the first dosing of the study will not be allowed to participate. * Subjects should not have donated blood and/or plasma for at least 30 days prior to the first dosing of the study. * Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allow to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Female subjects who have used hormonal oral contraceptives within 180 days of dosing will not be allowed to participate. * Female subjects with a positive or inconclusive pregnancy test result will be withdrawn from the study. * Subjects who do not tolerate venipuncture will not be allowed to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 12 hour period. | Bioequivalence based on Cmax. |
| AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 12 hour period. | Bioequivalence based on AUC0-t. |
| AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 12 hour period. | Bioequivalence based on AUC0-inf. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Test (Lansoprazole) First 30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods. | 25 |
| Reference (Prevacid®) First 30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period. | 25 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention | Adverse Event | 0 | 1 |
| Second Intervention | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Test (Lansoprazole) First | Reference (Prevacid®) First | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 25 Participants | 50 Participants |
| Race/Ethnicity, Customized Black | 1 participants | 4 participants | 5 participants |
| Race/Ethnicity, Customized Caucasian | 24 participants | 20 participants | 44 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Region of Enrollment United States | 25 participants | 25 participants | 50 participants |
| Sex: Female, Male Female | 6 Participants | 12 Participants | 18 Participants |
| Sex: Female, Male Male | 19 Participants | 13 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Time frame: Blood samples collected over a 12 hour period.
Population: All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Lansoprazole) | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | 1998.063 ng*h/mL | Standard Deviation 1310.811 |
| Reference (Prevacid®) | AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity) | 2052.519 ng*h/mL | Standard Deviation 1467.575 |
90% CI: [92.8, 104]
Primary
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Time frame: Blood samples collected over a 12 hour period.
Population: All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Lansoprazole) | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | 1938.669 ng*h/mL | Standard Deviation 1187.39 |
| Reference (Prevacid®) | AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | 1982.598 ng*h/mL | Standard Deviation 1300.059 |
90% CI: [93.3, 104]
Primary
Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax.
Time frame: Blood samples collected over a 12 hour period.
Population: All participants that completed the study had their samples analyzed. Replicate study design allowed for 2 sets of samples per subject per treatment (N=96 for both test and reference).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test (Lansoprazole) | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 782.438 ng/mL | Standard Deviation 304.196 |
| Reference (Prevacid®) | Cmax (Maximum Observed Concentration of Drug Substance in Plasma) | 738.531 ng/mL | Standard Deviation 294.692 |
90% CI: [97.4, 114]