Clinical trials: Bio-equivalence Study
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
Scabies
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
This is a multi-center, double-blind, randomized, two arm parallel design study. This study is comprised of two phases: screening and treatment.
- Trial name
- NCT02978508
- Testing
- Permethrin Cream, 5%, Elimite
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- Mayne Pharma International Pty Ltd
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.
Melanoma
Trial of Autologous, Hapten-Modified Vaccine in Patients With Stage III or IV Melanoma
The purpose of this study is to determine whether a vaccine composed of patients' own melanoma cells treated with the chemical, dinitrophenyl (DNP)(called a hapten), is safe and stimulates an immune response to patients' own…
- Trial name
- NCT00257465
- Testing
- Autologous, DNP-modified vaccine (M-Vax), Autologous, DNP-Modified Melanoma Vaccine, Autologous, DNP-Modified Vaccine
- Where
- 7 sites in United States
- Volunteers
- 82 people
- Sponsor
- AVAX Technologies
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
Lymphoma Leukemia
To Study the Concentration Level of, Doxil, and Doxorubicin at Various Time Frames
Doxil or Doxorubicin to be administered was administered in a dose of 50 mg/m2 as infusion over 15 minutes. Blood samples to be obtained at 0, 1, 2, 3, 4, 8, 12, 24, 48 and 72 hours
- Trial name
- Doxil (NCT03975205)
- Testing
- Doxorubicin
- Where
- India
- Volunteers
- 500 people
- Sponsor
- Sutphin Drugs
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.
Acne Vulgaris
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
- Trial name
- NCT04321070
- Testing
- Clindamycin Phosphate, Clindamycin Phosphate RLD
- Where
- United States
- Volunteers
- 550 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
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.
Multiple Myeloma
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma
Safety and bioequivalence of SPARC_147709
- Trial name
- NCT00863174
- Testing
- SPARC147709, Reference147709
- Volunteers
- 24 people
- Sponsor
- Sun Pharma Advanced Research Company Limited
Acne Vulgaris
Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris
This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.
- Trial name
- NCT04134273
- Testing
- CLPG Topical Gel 1%, Clindamycin
- Where
- United States
- Volunteers
- 1,260 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
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