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Telmisartan

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Dec 27, 2018

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

Telmisartan · 1 trial · 1 indication

Phase 1 1
NCT03705533Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting StateBioequivalence
COMPLETED26 Analytics
PHASE1COMPLETED
Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State
Bioequivalence
NCT0370553326
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Study Endpoints

Primary Endpoints

Cmax of telmisartan for the test and the reference products
Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration

Maximum concentration in plasma among observed concentrations at pre-specified time points

AUC0-T of telmisartan for the test and the reference products
Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration

Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration

Secondary Endpoints

Tmax of telmisartan for the test and the reference products
Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
TLQC of telmisartan for the test and the reference products
Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
AUC0-∞ of telmisartan for the test and the reference products
Time points 0.00 (prior to drug administration) and 0.17, 0.33, 0.50, 0.67, 0.83, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 6.00, 9.00, 12.00, 16.00, 24.00, 36.00, 48.00, 72.00 hours after drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence ABABOTHERSubjects assigned to sequence ABAB will receive a single 80 mg dose of the test product Telmisartan (1 x 80 mg tablet) marked as A in the sequence in Periods 1 and 3 and a single 80 mg dose of the reference product Micardis (1 x 80 mg tablet) marked as B in the sequence in periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.
Sequence BABAOTHERSubjects assigned to sequence BABA will receive a single 80 mg dose of the reference product Micardis (1 x 80 mg tablet) marked as B in the sequence in periods 1 and 3 and a single 80 mg dose of the test product Telmisartan (1 x 80 mg tablet) marked as A in the sequence in Periods 2 and 4. These treatments will be administered orally with approximately 240 mL of water at ambient temperature, in the morning, following a 10-hour overnight fast. The tablet must be swallowed whole and must not be chewed or broken.

Interventions

NameTypeDescription
TelmisartanDRUGTelmisartan is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 80 mg of telmisartan.
MicardisDRUGMicardis is manufactured by Boehringer Ingelheim Ellas AE, Greece. Each tablet contains 80 mg of telmisartan.
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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 male or female adult volunteer 4. A female volunteer meeting one of the following criteria: * (1) ...

Countries:Canada
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Frequently asked questions about Telmisartan

What is Telmisartan used for?

Telmisartan is an investigational small molecule being studied for bioequivalence. It is being evaluated in a Phase 1 clinical trial to compare two formulations of Telmisartan 80 mg tablets in healthy adult volunteers under fasting conditions. The drug is not approved and is still in clinical development.

Who makes Telmisartan?

Telmisartan is being developed by Ligand Pharmaceuticals Incorporated, which trades under the ticker LGND. The company is conducting a Phase 1 bioequivalence study of the drug in healthy volunteers.

What phase is Telmisartan in?

Telmisartan is in Phase 1 clinical development. It is an investigational drug being studied for bioequivalence, and it is not yet approved. The Phase 1 trial has been completed.

What clinical trials is Telmisartan in?

Telmisartan has one completed clinical trial, NCT03705533, titled "Bioequivalence Study of Two Formulations of Telmisartan 80 mg Tablets in Healthy Adult Volunteers Under Fasting State." The trial enrolled 26 participants in Canada and was a randomized, controlled study.

Is Telmisartan the same as any other drug?

Telmisartan is the drug name provided, and no alternative names have been listed for it. It is being studied as a standalone small molecule for bioequivalence purposes.