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Atacand PROTECT

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Nov 18, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Atacand PROTECT · 1 trial · 1 indication

Phase 1 1
NCT04012307The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting ConditionsBioequivalence
COMPLETED40 Analytics
PHASE1COMPLETED
The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions
Bioequivalence
NCT0401230740
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Study Endpoints

Primary Endpoints

Cmax of candesartan in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.

Maximum observed concentration in plasma.

AUC0-t of candesartan in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.

Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) using the linear trapezoidal method.

Secondary Endpoints

Tmax of candesartan in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.
TLQC of candesartan in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.
AUC0-INF of candesartan in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00 hours after each drug administration.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence ABOTHER20 subjects assigned to the sequence AB will receive a single 32 mg dose of the test product Candesartan Cilexetil (1 x 32 mg tablet), marked as A in the sequence, in Period 1 and a single 32 mg dose of the reference product Atacand® PROTECT (1 x 32 mg tablet), marked as B in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
Sequence BAOTHER20 subjects assigned to the sequence BA will receive a single 32 mg dose of the reference product Atacand® PROTECT (1 x 32 mg tablet), marked as B in the sequence, in Period 1 and a single 32 mg dose of the test product Candesartan Cilexetil (1 x 32 mg tablet), marked as A in the sequence, in period 2. These treatments will be administered orally with approximately 240 mL of water, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.

Interventions

NameTypeDescription
Candesartan Cilexetil 32mgDRUGCandesartan Cilexetil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 32 mg of candesartan cilexetil.
Atacand® PROTECTDRUGAtacand® PROTECT is manufactured by AstraZeneca GmbH, Germany. Each tablet contains 32 mg of candesartan cilexetil.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF) 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Healthy Caucasian adult male or female 4. If female, meets one of the following criteria: (1) Physiological p...

Countries:Canada
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Frequently asked questions about Atacand PROTECT

What is Atacand PROTECT used for?

Atacand PROTECT is a small molecule drug being studied for bioequivalence, meaning it is evaluated to determine whether it produces the same effects in the body as a reference drug. It is an investigational product in clinical development and is not approved for any indication.

Who makes Atacand PROTECT?

Atacand PROTECT is being developed by Ligand Pharmaceuticals Incorporated, a biopharmaceutical company traded on the stock exchange under the ticker symbol LGND. The company is conducting clinical research on this drug candidate.

What phase is Atacand PROTECT in?

Atacand PROTECT is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its properties.

What clinical trials is Atacand PROTECT in?

Atacand PROTECT has one completed clinical trial, identified as NCT04012307, titled "The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting Conditions." This Phase 1 study enrolled 40 participants in Canada.

Is Atacand PROTECT the same as candesartan cilexetil?

Atacand PROTECT is being studied in a trial that compares two different formulations of candesartan cilexetil. The trial is designed to assess bioequivalence, meaning it evaluates whether the drug product containing candesartan cilexetil behaves the same as a reference formulation.