Recent Updates
Recently added Catalysts

Tritace

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Jan 8, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

Tritace · 2 trials · 1 indication

Phase 1 2
NCT05685277Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under Fasting ConditionsBioequivalence
COMPLETED50 Analytics
NCT05438316Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting ConditionsBioequivalence
COMPLETED50 Analytics
PHASE1COMPLETED
Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under Fasting Conditions
Bioequivalence
NCT0568527750
Unlock trial analytics
PHASE1COMPLETED
Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting Conditions
Bioequivalence
NCT0543831650
Unlock trial analytics

Study Endpoints

Primary Endpoints

Cmax of ramipril, ramiprilat and hydrochlorothiazide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 hours after each drug administration.

Maximum observed concentration in plasma.

AUC0-72 of ramipril, ramiprilat and hydrochlorothiazide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 hours after each drug administration.

Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration (TLQC) at the 72 hour time point using the linear trapezoidal method.

Cmax of ramipril and active metabolite ramiprilat in plasma after administration of the test and the reference products
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 hours after each drug administration.

Maximum observed concentration in plasma

AUC0-72 of ramipril and ramiprilat in plasma after administration of the test and the reference
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 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 ramipril, ramiprilat and hydrochlorothiazide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 hours after each drug administration.
TLQC of ramipril, ramiprilat and hydrochlorothiazide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 hours after each drug administration.
AUC0-INF of ramipril, ramiprilat and hydrochlorothiazide in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.10, 0.20, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.30, 3.00, 3.30, 4.00, 4.30, 5.00, 6.00, 8.00, 10.00, 12.00, 15.00, 24.00, 48.00, 72.00 hours after each drug administration.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Sequence TROTHER25 subjects assigned to the sequence TR will receive a single 10 mg/25 mg dose of the test product Ramipril/Hydrochlorothiazide (1 x 10 mg/25 mg tablet), marked as T in the sequence, in Period 1 and a single 10 mg/25 mg dose of the reference product Tritace® Plus (1 x 10 mg/25 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 RTOTHER25 subjects assigned to the sequence RT will receive a single 10 mg/25 mg dose of the test product Tritace® Plus (1 x 10 mg/25 mg tablet), marked as R in the sequence, in Period 1 and a single 10 mg/25 mg dose of the reference product Ramipril/Hydrochlorothiazide (1 x 10 mg/25 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
Ramipril/Hydrochlorothiazide tablet 10 mg/25 mgDRUGRamipril/Hydrochlorothiazide is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of ramipril and 25 mg of hydrochlorothiazide.
Tritace® Plus tablet 10 mg/25 mgDRUGTritace® Plus is manufactured by Sanofi S.p.A., Italy (holder of the registration certificate: Sanofi-Aventis Deutschland GmbH, Germany). Each tablet contains 10 mg of ramipril and 25 mg of hydrochlorothiazide.
Ramipril tablet 10 mgDRUGRamipril is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of ramipril.
Tritace® tablet 10 mgDRUGTritace® is manufactured by Sanofi-Aventis Deutschland GmbH, Germany. Each tablet contains 10 mg of ramipril.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy men or women aged between 18 to 45 years, inclusive; 2. Body mass index 18.5-30.0 kg/m², inclusive; 3. Verified diagnosis "healthy" according to the standard clinical, laboratory and instrumental examination methods; 4. The level of systolic blood pressure (SBP) ≥100 ...

Countries:Russia
Unlock Eligibility Criteria

Frequently asked questions about Tritace

What is Tritace used for?

Tritace is a small molecule drug being developed for bioequivalence studies. It is currently in Phase 1 clinical development, with two completed trials in healthy volunteers under fasting conditions. The drug is being studied to compare formulations of ramipril tablets.

Who makes Tritace?

Tritace is being developed by Ligand Pharmaceuticals Incorporated, a company traded on the stock exchange under the ticker symbol LGND. The company is conducting Phase 1 clinical trials for this drug in Russia.

What phase is Tritace in?

Tritace is in Phase 1 clinical development. It is an investigational drug, and its two clinical trials have been completed. The drug is not yet approved for any medical use, as it is still being studied for bioequivalence.

What clinical trials is Tritace in?

Tritace has two completed Phase 1 clinical trials. NCT05438316 is a bioequivalence study of two formulations of ramipril 10 mg tablets in healthy volunteers under fasting conditions. NCT05685277 is a bioequivalence study of ramipril/hydrochlorothiazide 10 mg/25 mg tablets in healthy volunteers under fasting conditions.

Is Tritace the same as ramipril?

Tritace is being studied as a formulation of ramipril, an ACE inhibitor. The clinical trials for Tritace compare different formulations of ramipril tablets, including a combination with hydrochlorothiazide. The drug is being tested for bioequivalence in healthy volunteers.