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Lansoprazole

Phase 4FDA approved

Undisclosed | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Trials Updated: Jan 5, 2011

Lansoprazole development status

FDA approval on record May 3, 2001
Approval holderTakeda Pharms Na
ApplicationNDA021281
Highest phase Phase 4 run by Takeda (NCT01135368)
Phase scored for RDYPhase 1
Registered trials 59 across 15 sponsors since Sep 2005

Lansoprazole target and mechanism

Molecular targetATP4A, ATP4B
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL480

Also known as Prevacid

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Lansoprazole clinical trials

Lansoprazole · 1 trial · 1 indication

Phase 1 1
NCT01270308Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting ConditionsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
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Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lansoprazole DR Capsules 30 mgEXPERIMENTALLansoprazole DR Capsules 30 mg of Dr.Reddy's Laboratories Limited
Prevacid 30 mg CapsulesACTIVE_COMPARATORPrevacid 30 mg Capsules of TAP Pharmaceuticals Inc. USA

Interventions

NameTypeDescription
LansoprazoleDRUGLansoprazole DR Capsules 30 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: i. Provided written informed consent. ii. Subject who were healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. iii. Subject having a body mass index between 18.0 and 29.9 (both inclusive), calculated as weight in Kg/height in m2...

Countries:India
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Frequently asked questions about Lansoprazole

What is Lansoprazole?

Lansoprazole is a small molecule drug developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. It is a Phase 1 investigational agent studied in healthy adult volunteers. Its clinical development has focused on bioequivalence testing rather than a disclosed patient indication.

What does Lansoprazole target?

Lansoprazole targets ATP4A and ATP4B. It acts as an inhibitor of these targets. ATP4A and ATP4B form the gastric proton pump, the enzyme complex responsible for secreting acid into the stomach, which is why inhibitors of this target class reduce gastric acid production.

Who makes Lansoprazole?

Lansoprazole is developed by Dr. Reddy's Laboratories Ltd, an Indian pharmaceutical company whose shares trade under the ticker RDY. Dr. Reddy's sponsored the clinical work recorded for this asset, including a Phase 1 bioequivalence study conducted in India.

What phase is Lansoprazole in?

Lansoprazole is in Phase 1 development. It is an investigational small molecule and is not described as approved. The single registered trial for this asset was a Phase 1 study, and it has completed, with no active trials currently listed.

What clinical trials is Lansoprazole in?

Lansoprazole has been studied in trial NCT01270308, titled Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions. That Phase 1 trial enrolled 48 healthy adult volunteers in India, used an active-controlled, randomized design, and is now completed.

Is Lansoprazole studied in healthy volunteers?

Yes. The registered Phase 1 trial of Lansoprazole, NCT01270308, was conducted in healthy volunteers rather than in patients with a specific disease. It enrolled 48 participants of any sex, aged 18 years and older, under fasting conditions in India.