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Aceclofenac film-coated

Phase 1

Bioequivalence | Small molecule | Other |Ligand Pharmaceuticals Incorporated|Last Updated: Jun 28, 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 Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05339373Bioequivalence Study of Two Formulations of Tablets Aceclofenac 100 mg in Healthy Volunteers Under Fasting ConditionsPHASE1 COMPLETED 36 — — Apr 15, 2022Aug 15, 2022Jun 28, 20231 Russia
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Study Endpoints
Primary Endpoints
Cmax of aceclofenac in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.

Maximum observed concentration in plasma.

AUC0-t of aceclofenac in plasma after administration of the test and the reference.
Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.

Cumulative area under the concentration time curve calculated from 0 to time of last observed quantifiable concentration using the linear trapezoidal method.

Secondary Endpoints
Tmax of aceclofenac in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
TLQC of aceclofenac in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
AUC0-INF of aceclofenac in plasma after administration of the test and the reference products.
Time points 0.00 (prior to each drug administration) and 0.15, 0.30, 0.45, 1.00, 1.15, 1.30, 1.45, 2.00, 2.20, 2.40, 3.00, 3.30, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 24.00 hours after each drug administration.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Sequence TROTHER18 subjects assigned to the sequence TR will receive a single 100 mg dose of the test product Aceclofenac (1 x 100 mg tablet), marked as T in the sequence, in Period 1 and a single 100 mg dose of the reference product Airtal ® (1 x 100 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 RTOTHER18 subjects assigned to the sequence RT will receive a single 100 mg dose of the test product Airtal ® (1 x 100 mg tablet), marked as R in the sequence, in Period 1 and a single 100 mg dose of thetest product Aceclofenac (1 x 100 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
Aceclofenac film-coated tablet 100 mgDRUGAceclofenac is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 100 mg of aceclofenac.
Airtal® film-coated tablet 100 mgDRUGAirtal ® is manufactured by Gedeon Richter- RUS", Russia / Gedeon Richter, Hungary. Each tablet contains 100 mg of aceclofenac.
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy european men or women aged between 18 to 45 years 2. The written consent of the volunteer to be included in the study 3. Verified diagnosis "healthy" according to the anamnesis data and the results of standard clinical, laboratory and instrumental examination methods,...

Countries:Russia
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