Lansoprazole 30 mg DR Capsule Fasting Study
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ClinicalTrials.gov Identifier: NCT01045967 |
Recruitment Status :
Completed
First Posted : January 11, 2010
Results First Posted : March 18, 2010
Last Update Posted : December 8, 2010
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: Lansoprazole Drug: Prevacid® | Phase 1 |
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA Bioequivalence Statistical Methods
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Official Title: | A Relative Bioavailability Study of Lansoprazole 30 mg DR Capsules Under Fasting Conditions. |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | June 2004 |
Actual Study Completion Date : | July 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: Invesigational Test Product
Lansoprazole 30 mg delayed-release Capsules
|
Drug: Lansoprazole
30 mg delayed-release Capsule |
Active Comparator: Reference Listed Drug
Prevacid® 30 mg delayed-release Capsules
|
Drug: Prevacid®
30 mg delayed-release Capsule
Other Name: Lansoprazole (generic name) |
- Cmax (Maximum Observed Concentration of Drug Substance in Plasma) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Blood samples collected over a 12 hour period. ]Bioequivalence based on AUC0-inf.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045967
United States, North Dakota | |
PRACS Institute, Ltd. | |
Fargo, North Dakota, United States, 58104 |
Principal Investigator: | James D Carlson, Pharm.D. | PRACS Institute, Ltd. |
ClinicalTrials.gov Identifier: | NCT01045967 History of Changes |
Other Study ID Numbers: |
B046530 |
First Posted: | January 11, 2010 Key Record Dates |
Results First Posted: | March 18, 2010 |
Last Update Posted: | December 8, 2010 |
Last Verified: | November 2010 |
Keywords provided by Teva Pharmaceuticals USA:
Bioequivalence Healthy Subjects |
Additional relevant MeSH terms:
Lansoprazole Dexlansoprazole Anti-Ulcer Agents Gastrointestinal Agents |
Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |