Recent Updates
Recently added Catalysts

Atacand PROTECT

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04012307The Bioequivalence Study of Two Different Formulations of Candesartan Cilexetil After a Single Oral Dose Administration Under Fasting ConditionsPHASE1 COMPLETED 40 — — Jul 11, 2019Aug 14, 2019Nov 18, 20191 Canada
Unlock Drug Trial Details
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.
Unlock Study Endpoints
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.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria