Clinical trials: Bioequivalence Study in Healthy Subjects
Heartburn
A Study to Compare Omeprazole Administered as Zegerid® Powder and as Prilosec® Capsule in Healthy Participants (P08050)(CL2010-12)
This study compares the bioequivalence of omeprazole administered as either Zegerid® powder for oral suspension 20 mg or as Prilosec 40 mg capsule to healthy participants.
- Trial name
- NCT01337804
- Testing
- omeprazole/sodium bicarbonate, omeprazole magnesium
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
Study in Healthy Volunteers to Prove That Two Different Formulations of Rotigotine Patches Deliver Equivalent Drug Amount to the Body
The major aim of this study is to investigate and compare the drug amount delivered to the body after sequential application of two Rotigotine patches of two different formulations
- Trial name
- NCT01059903
- Testing
- Rotigotine transdermal patch
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Pharmacology, Clinical
Bioequivalence Trial to Prove Equal Blood Concentrations of Two Different Fluconazole Formulations
Primary Objective: To compare the bioavailability of a single dose of fluconazole 150 mg capsules (Test product) with the bioavailability of a single dose of Diflucan™ capsules, 150 mg (Reference) administered under fasting…
- Trial name
- Orca (NCT03929861)
- Testing
- Fluconazole (BAYT006267) 150 mg capsules, Fluconazole 150 mg capsules (DiflucanTM)
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy Volunteers
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions.
- Trial name
- NCT04277624
- Testing
- fezolinetant - test formulation, fezolinetant - reference formulation
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Bioequivalence, Phase 1
A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects
This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy…
- Trial name
- NCT03273192
- Testing
- Adalimumab
- Where
- Iran
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Cinnagen
Diabetes Mellitus, Type 2
Bioequivalence Study of Two Albiglutide Drug Products in Healthy Adult Subjects
Albiglutide (Alb) is a novel analogue of glucagon-like peptide-1 (GLP-1) has been developed and approved for the treatment of type 2 diabetes mellitus.
- Trial name
- NCT02660736
- Testing
- Albiglutide Liquid Auto-injector, Albiglutide Lyophilized DCC Pen Injector
- Where
- United States
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01671722
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 500/50 Inhalation Powder/GSK in Healthy Volunteers
ioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT04546256
- Testing
- Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent, ADVAIR DISKUS® 500/50
- Where
- Greece
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
The objective of the current study is to establish the bioequivalence of linagliptin/ pioglitazone fixed dose combination tablet compared to single tablets of linagliptin and pioglitazone administered together.
- Trial name
- NCT01276327
- Testing
- Linagliptin + Pioglitazone, Linagliptin/Pioglitazone
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes
A Study of Pharmacokinetic Comparison of Two Recombinant Exendin-4 Formulations in Chinese Healthy Male Subjects
Evaluation of the pharmacokinetics and safety rE-4 Injection versus rE-4 Freeze-dried Powder in healthy subjects.
- Trial name
- NCT03199261
- Testing
- rE-4 Injection, rE-4 Freeze-dried Powder
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Healthy
Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test dexmethylphenidate hydrochloride formulation to an equivalent oral dose of the commercially available dexmethylphenidate…
- Trial name
- NCT00829673
- Testing
- Dexmethylphenidate Hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Bioequivalence - Irritation and Sensitization Potential of Transdermal Patch
Irritation and Sensitization Potential of Repeat Applications of Rotigotine Patch
STUDY TITLE: A Multiple Site Study to Evaluate the Irritation and Sensitization Potential of Repeat Applications of Rotigotine Transdermal System, 1 mg/24 hr Versus Neupro (Rotigotine Transdermal System), 1 mg/24 hr in Healthy…
- Trial name
- NCT02727205
- Testing
- Rotigotine Transdermal System
- Where
- 2 sites in United States, Canada
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- Inflamax Research Incorporated
Healthy
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fed Conditions
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under non-fasted…
- Trial name
- NCT01276080
- Testing
- Donepezil
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Bioequivalence of Pramipexole Extended Release (PPX ER) 1.5mg x 1 Tablet Once Daily (q.d.) vs. PPX ER 0.375mg x 4 Tablets Under Fasted and Fed Conditions in Japanese Healthy Volunteers
Bioequivalence between PPX ER 1.5 mg x 1 tablet q.d. and 0.375 mg PPX ER x 4 tablets q.d. under fasted and fed conditions Food effect of 1.5 mg ER x 1 tablet q.d.
- Trial name
- NCT01119443
- Testing
- PPX ER
- Where
- Japan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Multiple Sclerosis
Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy Volunteers
Biogen Idec has developed a novel process to manufacture Interferon beta-1a (INFB), the active ingredient of Avonex®, that does not include fetal bovine serum (FBS).
- Trial name
- NCT01500408
- Testing
- Interferon beta-1a (current approved manufacturing process invloving FBS), Interferon beta-1a (new process, manufactured without FBS)
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Biogen
Healthy
TMC114-TiDP3-C176 - A Study in Healthy Volunteers Investigating the Bioequivalence Between Two Commercially Available 400-mg Tablets to One New 800-mg Tablet of Darunavir (DRV) in the Presence of Low-dose Ritonavir Under Fed and Fasted Conditions
In this study participants will be given 800 mg darunavir, either as one 800-mg tablet formulation (G002), or as two commercially available 400-mg tablets formulation (F030), to evaluate the effect between both, in the presence…
- Trial name
- NCT01308658
- Testing
- Darunavir (DRV), ritonavir
- Where
- Germany
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Tibotec Pharmaceuticals, Ireland
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
Healthy Volunteers
Bioequivalence of Liquid and Reconstituted Lyophilized Subcutaneous Formulations of Caplacizumab.
The primary objective of the study is to evaluate the pharmacokinetic characteristics and demonstrate bioequivalence of a reconstituted new lyophilized formulation of caplacizumab for subcutaneous (s.c.) injection as compared to…
- Trial name
- NCT02189733
- Testing
- Caplacizumab
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ablynx, a Sanofi company
Healthy
Bioequivalence Study of Desloratadine and Pseudoephedrine Sulfate Extended-release Tablets Under Fasting Conditions
This is an open label randomised, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01373138
- Testing
- Desloratadine and pseudoephedrine
- Where
- Canada
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence Study of Pravastatin Sodium Tablets 80 mg Under Fed Conditions
This is a single Dose Two-Way Crossover Fed Bioequivalence Study of Pravastatin 80 mg Tablets of Dr.Reddy's Laboratories Limited with Pravachol 80mg, Bristol Myers Squibb in Healthy Volunteers.
- Trial name
- NCT01146093
- Testing
- Pravastatin Sodium
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
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