HealthyPhase 1NCT01046253

Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study

A Phase 1 study testing Lansoprazole and Prevacid® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Lansoprazole and Prevacid®
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Jan 2004to Jan 2004
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Gateway Medical Research, Inc.
Saint Charles, Missouri, 63301

Other trials in United States

About this study

Official title: A Relative Bioavailability Replicate Sprinkle Study of Lansoprazole 30 mg Delayed-Release Capsules Under Fasting Conditions

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Conditions: Healthy
Being tested: Lansoprazole, Prevacid®
Keywords: Bioequivalence, Healthy Subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LansoprazoleDrug
30 mg Delayed-Release Capsules
Prevacid®Drug
Also called Lansoprazole (generic name)
30 mg Delayed-Release Capsule

Study groups in NCT01046253
Study group	Role	What they receive
Investigational Test Product	Experimental	Lansoprazole 30 mg Delayed-Release Capsule Receives: Drug: Lansoprazole
Reference Listed Drug	Active comparator	Prevacid® 30 mg Delayed-Release Capsule Receives: Drug: Prevacid®

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax (Maximum Observed Concentration of Drug Substance in Plasma)
Bioequivalence based on Cmax.
Measured: Blood samples collected over a 12 hour period.
AUC0-t (Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
Bioequivalence based on AUC0-t.
Measured: Blood samples collected over a 12 hour period.
AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)
Bioequivalence based on AUC0-inf.
Measured: Blood samples collected over a 12 hour period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2004Jan 2004

First posted11 Jan 2010 (estimated)
Study startJan 2004
Primary completionJan 2004
Study completionJan 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01046253
Sponsor's protocol ID: B036579
Status last verified: Nov 2010
First submitted: 8 Jan 2010
Last updated: 8 Dec 2010
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Relative Bioavailability Replicate Sprinkle Study of Lansoprazole 30 mg Delayed-Release Capsules Under Fasting Conditions
ClinicalTrials.gov ID: NCT01046253
Acronym / sponsor ID: B036579
Conditions: Healthy
Keywords: Bioequivalence, Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Teva Pharmaceuticals USAIndustry (pharma, biotech, devices)
Study start: Jan 2004
Primary completion: Jan 2004 (actual)
Study completion: Jan 2004 (actual)
First posted: 11 Jan 2010 (estimated)
Results: Posted 19 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA Bioequivalence Statistical Methods

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Investigational Test Product	Experimental	Drug: LansoprazoleLansoprazole 30 mg Delayed-Release Capsule
Reference Listed Drug	Active comparator	Drug: Prevacid®Prevacid® 30 mg Delayed-Release Capsule

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lansoprazole30 mg Delayed-Release Capsules	Drug	Investigational Test Product
Prevacid®Also: Lansoprazole (generic name)30 mg Delayed-Release Capsule	Drug	Reference Listed Drug

Primary outcome

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.

Results and safety

Results posted to the registry on 19 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test (Lansoprazole) First	25	25
Reference (Prevacid®) First	25	25

Primary outcome: Cmax (Maximum Observed Concentration of Drug Substance in Plasma)

Time frame: Blood samples collected over a 12 hour period.. Mean (Standard Deviation). Unit: ng/mL

Measure	Test (Lansoprazole) n = 96	Reference (Prevacid®) n = 96
Value	782.438 (304.196)	738.531 (294.692)

Test (Lansoprazole) vs Reference (Prevacid®): Ratio of the T/R geometric mean x 100: 105 (90% CI 97.4 to 114)

Population analysed: 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).

Primary outcome: 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.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Test (Lansoprazole) n = 96	Reference (Prevacid®) n = 96
Value	1938.669 (1187.39)	1982.598 (1300.059)

Test (Lansoprazole) vs Reference (Prevacid®): Ratio of the T/R geometric mean x 100: 98.5 (90% CI 93.3 to 104)

Primary outcome: AUC0-inf (Area Under the Concentration-time Curve From Time Zero to Infinity)

Time frame: Blood samples collected over a 12 hour period.. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Test (Lansoprazole) n = 96	Reference (Prevacid®) n = 96
Value	1998.063 (1310.811)	2052.519 (1467.575)

Test (Lansoprazole) vs Reference (Prevacid®): Slope: 98 (90% CI 92.8 to 104)

Adverse events

Time frame: Adverse event data was collected over the course of the study, which was approximately 2 weeks in duration.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test (Lansoprazole) First	0 of 50 (0%)	0 of 50 (0%)	Not reported
Reference (Prevacid®) First	0 of 50 (0%)	0 of 50 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ali Ziaee, M.D. principal investigator

Cetero Research, San Antonio

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lansoprazole and Prevacid® in people with Healthy, run by Teva Pharmaceuticals USA at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (Maximum Observed Concentration of Drug Substance in Plasma) (time frame: Blood samples collected over a 12 hour period.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01046253.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2010; AzTrials last refreshed its copy on 30 Oct 2026.