Clinical trials: Therapeutic Equivalency
Ovarian Cancer, Malignant Female Reproductive System Neoplasm
A Crossover Bioequivalence Study of Intravenously Administered ATI0918 and DOXIL/CAELYX in Patients With Ovarian Cancer
The purpose of this study is to find the answers to the following research question(s): 1. Is the study drug equivalent to the approved drug, Doxil/Caelyx, and does it act the same way in the body as the approved drug? ATI-0918…
- Conditions
- Ovarian Cancer, Malignant Female Reproductive System Neoplasm, Cancer, Ovarian Tumor
- Trial name
- NCT01715168
- Testing
- DOXIL/CAELYX, ATI-0918
- Where
- 2 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- Azaya Therapeutics, Inc.
Healthy
Fasting Study of Quinapril Hydrochloride Tablets 40 mg and Accupril® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan quinapril hydrochloride 40 mg tablets compared to Parke-Davis Accupril® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose under fasting…
- Trial name
- NCT00649103
- Testing
- Quinapril Hydrochloride Tablets 40 mg, Accupril® Tablets 40 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets Under Fasting Conditions
Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets 15 mg/850 mg and Actoplus Met® (pioglitazone hydrochloride and metformin hydrochloride)…
- Trial name
- NCT01800227
- Testing
- Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Type 2 Diabetes
Bioequivalence Study for Fixed Dose Combination Zemimet® SR Tab. 50/1000 and Coadministration of Gemigliptin 50 mg and Metformin 1000 mg.
To determine and compare the rate and extent of absorption of gemigliptin/metformin hydrochloride sustained release 50/1000 mg FDC tablet (Zemimet® SR Tab.
- Trial name
- NCT04317703
- Testing
- Gemigliptin tartrate sesquihydrate and metformin, gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release
- Where
- Thailand
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy
Fed Study of Mylan Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
The objective of this study was to investigate the bioequivalence of Mylan nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed…
- Trial name
- NCT01018342
- Testing
- Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg, Macrobid® Capsules 100 mg
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
The objective of this study was to investigate the bioequivalence of Mylan's olmesartan medoxomil 40 mg tablets to Sankyo's Benicar® 40 mg tablets following a single, oral 40 mg (1 x 40 mg) dose administered under fasting…
- Trial name
- NCT00649623
- Testing
- Olmesartan Medoxomil Tablets 40 mg, Benicar® Tablets 40 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Trypanosomiasis, African
Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation
Phase 1 bioequivalence (BE) study. This study is for regulatory purpose to determine BE of the tablet formulation used in the clinical trials and the final marketed tablet formulation under fed condition.
- Trial name
- NCT02571062
- Testing
- Fexinidazole
- Where
- France
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Antithrombic Drug
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under…
- Trial name
- NCT06043297
- Testing
- Apixaban 5MG, Eliquis 5 mg
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalence of Two Azilsartan Formulations
Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers
The purpose of this study was to determine the bioequivalence of two azilsartan formulations after administration of single doses to healthy subjects under fasted and fed conditions.
- Trial name
- NCT03652792
- Testing
- Azilsartan (Zhaoke), Azilsartan (Takeda)
- Where
- Hong Kong
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Lee's Pharmaceutical Limited
Healthy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fed Conditions
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertaline, administered as a 1X100 mg tablet, under fasted conditions.
- Trial name
- NCT00946036
- Testing
- Sertraline Hydrochloride
- Where
- Canada
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy Vollunteer
Multiple Dose, Bioequivalence Study of Generic Alfuzosin Hydrochloride 10 mg Prolonged-release Tablets Under Fed Conditions
Objectives: To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose after multiple oral dose administration in healthy…
- Trial name
- BE24-005 (NCT06316336)
- Testing
- Alfuzosin Hydrochloride 10 mg, Xatral® XL 10 mg
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Pharma Nueva
Parkinson's Disease
Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets
The main purpose of In two kinds of fasting and postprandial Chinese healthy subjects with Boehringer represent Ingelheim company production of hydrochloric acid Pramipexole zyban (specification: 0.26 mg/piece, in Pramipexole…
- Trial name
- PLKS-BE (NCT04275492)
- Testing
- Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride), Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital of Zhejiang University
Diabetes Mellitus, Type 2, Healthy Participants
A Research Trial Looking at the Comparability of 2 Different Concentrations of Semaglutide for the 0.5 Milligram (mg) Dose
In this study, a known investigational medicine called 'semaglutide' will be tested in 2 drug concentrations of 0.68 milligram per milliliter (mg/mL) and 1.34 mg/mL.
- Trial name
- NCT05689099
- Testing
- Semaglutide B, 1.34 mg/mL, Semaglutide B, 0.68 mg/mL
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Cancer - Ovarian
A Study Evaluating the Bioavailability and Food Effect of Veliparib Tablets Followed by an Extension in Subjects With Ovarian Cancer
This study will evaluate the bioavailability between the veliparib tablet formulation to the capsule formulation; and will assess the effect of food on veliparib bioavailability in participants with ovarian cancer.
- Trial name
- NCT03400306
- Testing
- Veliparib, capsule, Veliparib, tablet, Carboplatin
- Sponsor
- AbbVie
Healthy Volunteer
Bioequivalence Study of Empagliflozin 25 mg Film-coated Tablets in Healthy Thai Volunteers
To determine and compare the rate and extent of absorption of a test formulation with that of a reference innovator formulation when given as equal labeled dose in healthy subjects under fasting conditions
- Trial name
- NCT06337409
- Testing
- Generic empagliflozin 25 mg film-coated tablets
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- International Bio service
Gastric Ulcer
Study to Evaluate the Bioequivalence of Vonopzan Tablet 20mg(Vonoprazan Fumarate) and Vocinti Tablet 20mg in Healthy Adult Subjects.
This clinical trial is an open-label, randomized, fasting, single-dose, two-sequence, two-period, crossover study in healthy subjects to evaluate the bioequivalence of "Vonopzan Tablets 20 mg(Vonoprazan Fumarate)" of Hanlim…
- Trial name
- NCT06642987
- Testing
- Vonoprazan Test 20mg, Vonoprazan Reference 20mg
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Hanlim Pharm. Co., Ltd.
Bioequivalence
Comparison of Two Formulations of Androxal
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
- Trial name
- NCT01984398
- Testing
- 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B, 25 mg Androxal Formulation A
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
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.
Allergy
Bioequivalence Study of Two Inhalation Formulations Containing Budesonide 200 µg
A SINGLE CENTER, SINGLE DOSE, OPEN-LABEL, RANDOMIZED, TWO PERIOD CROSSOVER STUDY TO DETERMINE THE BIOEQUIVALENCE OF TWO INHALATION FORMULATIONS CONTAINING BUDESONIDE 200 µg ADMINISTERED AS 3 PUFFS (TOTAL DOSE OF 600 µg) IN AT…
- Trial name
- NCT02593500
- Testing
- Budesonida Pulmictan® 200 µg, Budesonide 200 µg
- Where
- South Africa
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Reig Jofre Group
Healthy
A Bioequivalence Study of Norgestimate /Ethinyl Estradiol (NGM/EE) Tablets Manufactured at 2 Different Facilities
The purpose of this study is to establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in norgestimate/ethinyl estradiol (NGM/EE) tablets, formulated by wet process compared with the same…
- Trial name
- NCT02127593
- Testing
- Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process), Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)
- Where
- Netherlands
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
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