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Torasemide

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Jun 29, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04921566Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting ConditionsPHASE1 COMPLETED 26 — — Jun 5, 2021Jun 20, 2021Jun 29, 20231 Russia
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Study Endpoints
Primary Endpoints
Cmax of torasemide in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration.

Maximum observed concentration in plasma.

AUC0-t of torasemide in plasma after administration of the test and the reference.
Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 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 torasemide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
TLQC of torasemide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
AUC0-INF of torasemide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 1.75, 2.00, 3.00, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00 hours after each drug administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Sequence TROTHER13 subjects assigned to the sequence TR will receive a single 10 mg dose of the test product Torasemide (1 x 10 mg tablet), marked as T in the sequence, in Period 1 and a single 10 mg dose of the reference product Toradiur® (1 x 10 mg tablet), marked as R in the sequence, in period 2. These treatments will be administered orally with approximately 200 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 RTOTHER13 subjects assigned to the sequence RT will receive a single 10 mg dose of the reference product Toradiur® (1 x 10 mg tablet), marked as R in the sequence, in Period 1 and a single 10 mg dose of the test product Torasemide (1 x 10 mg tablet), marked as T in the sequence, in period 2. These treatments will be administered orally with approximately 200 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
Torasemide tablet 10 mgDRUGTorasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide.
Toradiur® tablet 10 mgDRUGToradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy caucasian men and women aged between 18 to 45 years 2. Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods, physical examination and anamnestic examination 3. Body mass inde...

Countries:Russia
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