Clinical trials: Bio-equivalence Study
DFU, VLU
BIO-SEE: Bioburden Imaging Outcome Study for Equivalence Evaluation
The study aims to demonstrate the substantial equivalence of the cureVision cV system's performance in detecting moderate to high bacterial loads in direct comparison to the comparator device for fluorescence imaging in wounds…
- Conditions
- DFU, VLU, Surgical Wound, Wounds
- Trial name
- NCT07611318
- Testing
- cureVision cV
- Where
- 5 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Capsicure, LLC
Healthy Volunteers
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects
The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.
- Trial name
- NCT01055769
- Testing
- Linezolid
- Where
- China
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Elbanovir 400 mg Film Coated Tablets ( Multi-Apex…
- Trial name
- NCT02605798
- Testing
- Elbanovir, Sovaldi
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Sofodelevier 400 mg F.C.T (Al-debeiky pharma, Egypt)…
- Trial name
- NCT03062423
- Testing
- Sofodelevier, Sovaldi (fist dose), Sovaldi (second dose)
- Where
- Egypt
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Erectile Dysfunction
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
The purpose of this study is to perform a relative bioavailability study between two formulations of sildenafil citrate.
- Trial name
- A1481272 (NCT00904748)
- Testing
- sildenafil citrate 100 mg CT, Viagra®
- Where
- Brazil
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Falciparum Malaria
Bioequivalence Study Comparing Artesunate Tablet To Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
The study will determine if artesunate tablet (Pfizer), an antimalarial agent, is pharmaceutically equivalent to Arsuamoon® tablets (Guilin-China).
- Trial name
- NCT00894374
- Testing
- Artesunate (Test), Artesunate (Comparator)
- Where
- Singapore
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pfizer
Infection, Human Immunodeficiency Virus
Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine
This study aims to compare the bioequivalence of two experimental fixed dose combination (FDC) tablets versus single entity products of dolutegravir (DTG) and lamivudine (3TC) in healthy adult subjects.
- Trial name
- NCT03078556
- Testing
- Dolutegravir, Lamivudine, Dolutegravir + Lamivudine FDC Formulation 1
- Where
- United States
- Volunteers
- 154 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Hyperlipidemias
HDDO-1756 Bio Equivalence Study
For healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of HDDO-1756 alone administration and HDDO-17561/HDDO-17562 combined administration.
- Trial name
- NCT04755894
- Testing
- HDDO-1756, HDDO-17561/HDDO-17562
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Healthy
Pivotal Bioequivalence Study of Topically Delivered Clobetasol Propionate Lotion in Healthy Adult Subjects
To compare the relative vasoconstrictive effects of two topical clobetasol propionate 0.05% lotions in asymptomatic subjects.
- Trial name
- NCT00864500
- Testing
- Clobetasol Propionate 0.05% lotion, single exposure, Clobex TM 0.05% Lotion, single exposure
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Bioequivalency, Safety Issues
Bioequivalence Study of Iron Sucrose Injection in Healthy Participants
The goal of this clinical trial is to compare the pharmacokinetic profile of the single intravenous injection of the test product and reference product in healthy subjects and to evaluate the bio-equivalence and safety of these…
- Trial name
- NCT06674486
- Testing
- Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd) and Iron Sucrose injection (Reference product, Venofer), Iron Sucrose injection (Reference product, Venofer) and Iron Sucrose injection (Test product, manufactured by Sichuan Huiyu Pharmaceutical Co., Ltd)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Bioequivalence Study
Bio-equivalence Vasoconstriction Activity Study for Topically Applied Clocortolone Pivalate 0.1% Cream
To compare pharmacodynamic vasoconstriction response profile of Clocortolone Pivalate 0.1% Cream and Cloderm® (Clocortolone Pivalate) 0.1% Cream in normal skin of healthy male and female adults
- Trial name
- NCT04358770
- Testing
- Clocortolone Pivalate
- Where
- United States
- Volunteers
- 124 people, healthy volunteers welcome
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Fasting
Bioequivalence Study of Amlodipine / Losartan/ Hydrochlorothiazide of PHARMALINE, Lebanon Under Fastion Conditions
To assess the bioequivalence of the investigational TEST product with the marketed REFERENCE products by measurement of Plasma concentrations of Amlodipine ,Losartan, Carboxylic acid losartan metabolite \& Hydrochlorothiazide in…
- Trial name
- NCT01713647
- Testing
- Amlodipin, losartan, HCTZ
- Where
- Jordan
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Pharmaceutical Research Unit, Jordan
Bio-equivalence Study, Fed Conditions
Fed Bioequivalence Study of CBZ Formulations
Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction.
- Trial name
- NCT02132897
- Testing
- Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose, Tegretol CR 400 Single Dose-Auration CR 400 Single Dose
- Where
- Uruguay
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.
Japanese Healthy Adult Male Participants
A Phase 1, Bio-equivalence Study of TAK-536 Pediatric Formulation
The purpose of this study is to evaluate the bio-equivalence of a single oral administration of TAK-536 pediatric formulation (granules) in comparison with a TAK-536 commercial formulation (tablet) in Japanese healthy adult male…
- Trial name
- NCT03042299
- Testing
- TAK-536
- Where
- Japan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Subjects, Human Volunteers
Bio-Equivalence Study of Budesonide Prolonged-release Tablets 9 Mg In Healthy Human Adult Subjects
A randomized, open label, single dose, balanced, two treatment, two sequence, four period, fully replicate, cross over bioequivalence study under fasting condition.
- Conditions
- Healthy Subjects, Human Volunteers, Healthy Participants, Bioequivalence
- Trial name
- NCT05519514
- Testing
- Cortiment, Budesonide
- Where
- India
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Abbott
Healthy
A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada)
Comparative randomized, single dose, three way three sequence two treatment partial replicate crossover open-label study to determine the bioequivalence of Sofosbuvir from Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma…
- Trial name
- NCT02953535
- Testing
- Magicbuvir, Sovaldi (fist dose), Sovaldi (second dose)
- Where
- Egypt
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy Subjects
Bio Equivalence Study of Torrent Pharmaceutical Ltd's Rosuvastatin Calcium Tablets Under Fasting Condition.
Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets 40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA.
- Trial name
- NCT02962310
- Testing
- Torrent's Rosuvastatin Calcium Tablets 40 mg, Crestor 40 mg Tablets of AstraZeneca LP, USA
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Bioequivalence, Bioavailability
Bio-equivalence Study
The primary objective of this study is to compare absorption of vitamin K2 (menaquinone-7) after intake of three different vitamin K2 supplements.
- Trial name
- NCT01638143
- Testing
- MenaQ7 M-1500 capsules, Gnosis P-1000 capsules, Gnosis M-1500 capsules
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
Osteoporosis
HDDO-1614 Bio Equivalence Study
A randomized, open-label, single-dose, crossover study
- Trial name
- NCT03382314
- Testing
- HDDO-1614, Bazedoxifene / Cholecalciferol
- Where
- South Korea
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Healthy
A Pivotal Study to Evaluate the Bio-equivalence of the Tapentadol Extended-Release (ER) Tamper-resistant Formulation (TRF) Tablet to the Current Tapentadol ER Prolonged-release 2 (PR2) Tablet
The purpose of this study is to evaluate bio-equivalence of tapentadol extended-release (ER) tamper-resistant formulation (TRF) tablet, to the current tapentadol ER, prolonged-release formulation 2 (PR2) tablet, in healthy…
- Trial name
- NCT01900587
- Testing
- Tapentadol ER Tamper-resistant Formulation (TRF), Tapentadol ER Prolonged-Release 2 (PR2)
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.