Clinical trials: Bioequivalence
Healthy
Bioavailability Study of Ondansetron 24 mg Orally Disintegrating Tablets Under Fasting Conditions
Single-dose cross over comparative bioavailability of Ondansetron 24 mg oDT and Zofran 24 mg ODT
- Trial name
- NCT00659074
- Testing
- Ondansetron, Zofran
- Where
- Canada
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Acne Vulgaris
Double-blind Placebo-controlled Trial of Generic Clindamycin/Benzoyl Peroxide Gel Versus Onexton Gel in Acne Vulgaris
Actavis has developed a generic formulation of clindamycin 1.2% and benzoyl peroxide 3.75% gel. This study is designed to evaluate the safety and efficacy of this formulation in subjects with Acne Vulgaris
- Trial name
- NCT02616614
- Testing
- Onexton, Clindamycin/benzoyl peroxide gel
- Where
- 17 sites in United States
- Volunteers
- 862 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Chronic Kidney Failure, Anaemia
Bioequivalence of a Single Subcutaneous Dose of Epoetin Beta in Healthy Japanese and Caucasian Male Subjects
A study to see how a single subcutaneous dose of Epoetin beta (NeoRecormon®) in healthy Japanese compares with a single subcutaneous dose of Epoetin beta (NeoRecormon®) in Caucasian Male subjects.
- Trial name
- NCT01085552
- Testing
- Epoetin Beta
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- InCROM Europe Clinical Research
Healthy
Bioequivalence of Two Formulations of Levothyroxine Sodium 200 Micrograms (mcg) Under Tablet Form
The study was to verify if the test formulation of Levothyroxine sodium presents an equivalent rate and extension of absorption to the comparator formulation when administered with the same dosage and under fasting conditions and…
- Trial name
- NCT04037748
- Testing
- Puran T4®, Eutirox®
- Where
- Brazil
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Hyperphosphatemia
Bioequivalence Study of BAY77-1931 Granule
The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population is 60 Japanese healthy male adult subjects selected by screening examination which will be conducted within 4 weeks before the first…
- Trial name
- NCT01053676
- Testing
- Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule, Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
- Where
- Japan
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy, Obesity
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product [formulation A]) and in a vial (test product [formulation B2]) in male and female trial participants…
- Trial name
- NCT07768813
- Testing
- Survodutide formulation A, Survodutide formulation B2
- Where
- Germany
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Hemophilia A
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate…
- Trial name
- NCT00141843
- Testing
- ReFacto AF, B-Domain deleted Recombinant Factor VIII, BDDrFVIII
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Healthy
Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg
The objective of this study was to investigate the bioequivalence of Mylan's divalproex sodium 500 mg extended-release tablets to Abbott's Depakote ER® 500 mg tablets following a single, oral 500 mg (1 x 500 mg) dose administered…
- Trial name
- NCT00648076
- Testing
- Divalproex Sodium Extended-Release Tablets 500 mg, Depakote ER® Tablets 500 mg
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Pioglitazone Hydrochloride Tablets Under Fed Conditions
Objective: subjects to compare the single dose bioavailability of Torrent's Pioglitazone Hydrochloride Tablets 1 × 45 mg and Actos® Tablets 1 × 45 mg of Takeda Pharmaceuticals America, Inc.
- Trial name
- NCT01798940
- Testing
- Torrent's Pioglitazone
- Where
- India
- Volunteers
- healthy volunteers welcome
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
- Trial name
- NCT02841150
- Testing
- IMBRUVICA (Treatment A), Ibrutinib (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy Volunteers
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two octreotide microsphere formulations in healthy Chinese volunteers.
- Trial name
- NCT06254235
- Testing
- The test octreotide microsphere, The reference octreotide microsphere
- Where
- China
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Bioequivalence
Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace®, 10 mg tablets) or the test (Ramipril, 10 mg tablets)…
- Trial name
- NCT05438316
- Testing
- Ramipril tablet 10 mg, Tritace® tablet 10 mg
- Where
- Russia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the…
- Trial name
- NCT01257516
- Testing
- Pregabalin immediate release, 300 mg, Pregabalin controlled release, 330 mg
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence of BIBR 277 Tablet (Mannitol Based) Compared With Capsule Formulation in Healthy Male Volunteers
Study to investigate the bioequivalence of BIBR 277 tablet (Mannitol based) vs. BIBR 277 capsule
- Trial name
- NCT02262585
- Testing
- BIBR 277 tablet, BIBR 277 capsule
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence
A Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection
A Randomized,Open-label, Single-Dose,Two-Cycle,Cross- Bioequivalence Study of Doxorubicin Hydrochloride Liposome Injection Under Advanced Breast Cancers.
- Trial name
- NCT04460820
- Testing
- Doxorubicin Hydrochloride Liposome Injection
- Where
- China
- Volunteers
- 32 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via pre-filled syringe compared to mirikizumab (reference)…
- Trial name
- NCT05644353
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Ramipril 10 mg Capsules Under Fed Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing ramipril 10 mg capsules of Ohm Laboratories Inc., with Altace®…
- Trial name
- NCT00879788
- Testing
- Ramipril 10mg capsules
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Bioequivalence, Diabetes Mellitus, Type 2
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 100 mg /1000 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
The objective of this study was to evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of sitagliptin/metformin extended release tablets after a single oral dose…
- Trial name
- NCT06124573
- Testing
- Sitagliptin/Metformin HCl 100/1000 mg extended release film-coated tablet
- Where
- Mexico
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galenicum Health
Healthy
Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions
The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's Zonisamide 100 mg Capsule to that of Zonegran® 100 mg Capsule after a single, one-capsule dose in fasted subjects.
- Trial name
- NCT01161966
- Testing
- Zonisamide, Zonegran
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Relative Bioavailability Study of Glyburide/Metformin HCl 5 mg/500 mg Tablets Under Fasting Conditions
The purpose of this study is to compare the relative bioavailability of 5 mg Glyburide/500 mg Metformin Hydrochloride Tablets by Purepac Pharmaceutical Co.
- Trial name
- NCT00865241
- Testing
- Glyburide and Metformin Hydrochloride Tablets 5 mg/500 mg, CLUCOVANCE® 5 mg/500 mg Tablets, single dose
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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