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Torasemide

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

Torasemide · 1 trial · 1 indication

Phase 1 1
NCT04921566Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting ConditionsBioequivalence
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Two Formulations of Torasemide Tablet 10 mg in Healthy Volunteers Under Fasting Conditions
Bioequivalence
NCT0492156626
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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 to 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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Frequently asked questions about Torasemide

What is Torasemide used for?

Torasemide is a small molecule drug being studied for bioequivalence, meaning it is being tested to show that a new formulation of the drug is equivalent to an existing one. The specific study involves Torasemide tablets at a 10 mg dose in healthy volunteers under fasting conditions.

Who makes Torasemide?

Torasemide is being developed by Ligand Pharmaceuticals Incorporated, a company traded on the stock exchange under the ticker LGND. The company is conducting clinical research on this small molecule drug to assess its bioequivalence.

What phase is Torasemide in?

Torasemide 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, in this case, bioequivalence.

What clinical trials is Torasemide in?

Torasemide has one completed clinical trial with the identifier NCT04921566. This was a Phase 1 bioequivalence study of two formulations of Torasemide tablet 10 mg in healthy volunteers under fasting conditions, conducted in Russia with 26 participants.

Is Torasemide the same as torsemide?

Torasemide is a name for the drug that is also known as torsemide. The clinical trial for this drug uses the name Torasemide, and it is a loop diuretic medication. The study is evaluating the bioequivalence of two tablet formulations of this drug.