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Tritace

Phase 1

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

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 Trials2
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05685277Bioequivalence Study of Two Formulations of Tablets Ramipril/Hydrochlorothiazide 10 mg/25 mg in Healthy Volunteers Under Fasting ConditionsPHASE1 COMPLETED 50 — — Dec 28, 2022Jul 31, 2023Jan 8, 20241 Russia
NCT05438316Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting ConditionsPHASE1 COMPLETED 50 — — Jun 17, 2022Nov 17, 2022Jun 29, 20231 Russia
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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.
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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.
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Eligibility Criteria
Age Range18 Years — 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
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