Clinical trials: Therapeutic Equivalency, active
Healthy Participants
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine Hydrochloride Enteric-coated Tablets in Healthy Participants.
Evaluation of Bioequivalence and Food Effect of a New Strength Formulation of Ammoxetine hydrochloride Enteric-coated Tablets in Healthy Participants.The study is composed of 2 parts.
- Trial name
- NCT07756996
- Testing
- Ammoxetine hydrochloride Enteric-coated Tablets(new formulation), Ammoxetine hydrochloride Enteric-coated Tablets(Phase III formulation)
- Where
- China
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1622, DWC202313, and DWC202314 in Healthy Volunteers Under Fasting Conditions
This study aims to evaluate the safety and pharmacokinetic characteristics of DWJ1622, DWC202313, and DWC202314 in healthy adult volunteers under fasting conditions.
- Trial name
- NCT07260851
- Testing
- DWJ1622, DWC202313, DWC202314
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Hyperprolactinemia
A Study on Bioequivalence of Cabergoline Tablets in Human Body
The purpose of this study is to evaluate the bioequivalence of the test formulation and reference formulation of cabergoline tablets in healthy Chinese subjects under fasting and postprandial conditions.
- Trial name
- NCT07008417
- Testing
- Cabergoline tablets test formulation, Cabergoline tablets reference formulation
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Acute Myeloid Leukemia
Extension Study, Pilot, Compassionate Use of Azacitidine 300 mg Film Coated Tablets for Acute Myeloid Leukaemia (AML) Patients
Extension study, pilot, single-arm, compassionate use of Hikma Azacitidine 300 mg Film coated tablets test product for the Acute Myeloid Leukaemia (AML) patients who completed Hikma bioequivalence study with protocol number…
- Trial name
- NCT06572982
- Testing
- Azacitidine
- Where
- United Arab Emirates
- Volunteers
- 20 people
- Sponsor
- Hikma Pharmaceuticals LLC
Healthy Participants
A Phase 1 Study of Navlimetostat Tablet Formulations
This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female
- Trial name
- NCT07544628
- Testing
- Navlimetostat
- Where
- 4 sites in United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Myeloma Multiple
Bioequivalence Studies of Dasatinib 100 Mg
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg…
- Trial name
- BE-Dasatinib (NCT05944783)
- Testing
- Dasatinib 100 MG
- Where
- Colombia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Breast Cancer
Bioequivalence ANDA SNP Clinical Study - Raloxifene and Single Nucleotide Polymorphisms
Explore the relationship between drug target ER gene single nucleotide polymorphisms and Raloxifene therapeutic effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.
- Trial name
- Drugs-SNPs (NCT06062810)
- Testing
- Raloxifene - Usual, Raloxifene - Study
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Healthy
A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
- Trial name
- NCT07789028
- Testing
- Zongertinib, Formulation A, reference product, Zongertinib Formulation B, test product
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy, Healthy Donors
Bioequivalence Study of Pentoxifylline 400 Mg in Healthy Subjects Under Fasting and Fed Conditions
Two bioequivalence studies of Pentoxifylline will be carried out in 40 healthy subjects, the first in a fasting condition 40 healthy subjects, the first in fasting condition and the second in postprandial condition.
- Trial name
- Pentoxifylline (NCT06823362)
- Testing
- Pentoxifylline
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Healthy Subjects (HS)
Bioequivalence Study Between YHP2508B and YHR2602 in Healthy Subjects
An open-label, randomized, fasting, single-dose, oral administration, 2-sequence, 4-period, replicate crossover study to evaluate bioequivalence between YHP2508B and YHR2602 in healthy subjects.
- Trial name
- NCT07912840
- Testing
- YHP2508B, YHR2602
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Obesity&T2D
Bioequivalence Study of GZR18 Injection Before and After CMC Change
This is an open-label, randomized, single-dose, parallel comparison bioequivalence study conducted in healthy adult male subjects.
- Trial name
- NCT07355738
- Testing
- GZR18 injection A, GZR18 injection B
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Gan & Lee Pharmaceuticals.
Prostatic Neoplasms
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer
The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under…
- Trial name
- NCT04577833
- Testing
- Niraparib, Abiraterone Acetate (AA), Prednisone
- Where
- 16 sites in United States, Belgium and 9 more
- Volunteers
- 136 people
- Sponsor
- Janssen Research & Development, LLC
Irritable Bowel Syndrome, Gallstone Disease
Pharmacokinetics, Bioequivalence, and Safety Study of Trimedat® 76,95 mg Orally Disintegrating Tablets and Trimedat® 100 mg Tablets in Healthy Volunteers.
This study aims to evaluate pharmacokinetic profile, safety and establish bioequivalence of the investigational drug Trimedat® 76,95 mg orally disintegrating tablets compared to the reference drug Trimedat® 100 mg tablets in…
- Conditions
- Irritable Bowel Syndrome, Gallstone Disease, GERD, Biliary Dyskinesia
- Trial name
- NCT07421011
- Testing
- Trimedat®
- Where
- Russia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy, Healthy Donors
Bioequivalence Study of Lithium Carbonate 300 mg Tablets. Actilitio® in Healthy Subjects
A bioequivalence study of lithium carbonate will be developed in 24 healthy subjects, in fasting condition
- Trial name
- NCT06861842
- Testing
- Theralite®, Actilitio®
- Where
- Colombia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Hypertension
A Bioequivalence and Safety Study of AJU-C719 and C719R in Healthy Adult Volunteers
To evaluate the bioequivalence and safety of "AJU-C719" and "C719R" in healthy adult subjects.
- Trial name
- NCT07901114
- Testing
- Test Drug, Reference Drug
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AJU Pharm Co., Ltd.
Healthy Volunteers, Male
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin 0.4 mg Tablets, in Healthy Adult Male Subjects, Under Fed Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0,4 mg…
- Trial name
- NCT07091669
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group
Primary Hypercholesterolaemia
A Study to Compare PK Characteristics and Safety Profiles Between AD-228B and AD-2284
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-228B in healthy subjects.
- Trial name
- NCT06884098
- Testing
- AD-228B, AD-2284
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Benign Prostatic Hyperplasia
A Clinical Trial to Evaluate the Bioequivalence of AD-116A and AD-1161 Under Fed Conditions in Healthy Adult Male Volunteers
This study compares and evaluates the bioequivalence of AD-116A and AD-1161 in healthy adult male volunteers under fed conditions.
- Trial name
- NCT07722871
- Testing
- AD-116A, AD-1161
- Where
- South Korea
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Addpharma Inc.
Chronic Graft Versus Host Disease
Study to Compare the Plasma Concentration of Belumosudil Given as an Oral Suspension and as a Tablet to Healthy Adult Male Participants
The purpose of this open-label, randomized, cross-over, Phase 1, 2-treatment, 2-period, 2-sequence study is to assess the bioequivalence of belumosudil oral suspension compared with belumosudil tablet in healthy male participants…
- Trial name
- NCT07726914
- Testing
- Belumosudil
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Sanofi
Hypertension
Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia)
ACEis are among the most widely used classes of antihypertensive drugs. ARBs have a similar antihypertensive efficacy and protective effect as ACEis, albeit with a somewhat different mechanism for RAS inhibition and a smaller…
- Trial name
- NCT06990204
- Testing
- Azilsartan medoxomil 80 mg tablet, Edarbi® 80 mg tablets
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.