Clinical trials: Bioequivalence
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.
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
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
Tobacco Use Disorder
To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers
This study will assess the bioequivalence of the test product (Nicotine Prototype Mini lozenge 4 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini lozenge 4mg) in healthy smokers under fasting…
- Trial name
- NCT03543137
- Testing
- Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
The Relative Bioavailability Study of Two Ropinirole 0.25 mg Tablets Under Fed Conditions
The purpose of this study is to compare relative bioavailability of the test formulation of ropinirole hydrochloride 0.25 mg tablets (Manufactured and distributed by TEVA Pharmaceuticals USA) with the already approved formulation…
- Trial name
- NCT00830219
- Testing
- Ropinirole HCl 0.25 mg Tablets, Requip® 0.25 mg Tablets
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Major Depressive Disorder
Clinical Study of Generic and Brand Bupropion in Depression
Determine bioequivalence between branded and generic bupropion extended release (XL) products (and between generic products) at steady state in patients with major depressive disorder.
- Trial name
- BALANCE (NCT02209597)
- Testing
- Bupropion XL 300
- Where
- United States
- Volunteers
- 74 people
- Sponsor
- Washington University School of Medicine
Healthy
Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions.
- Trial name
- NCT01124162
- Testing
- Losartan, Cozaar®
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
A Study to Evaluate Zilucoplan Injected Subcutaneously Either by a Prefilled Syringe or an Auto-injector in Healthy Adult Participants
The purpose of this study is to assess the bioequivalence pharmacokinetics, safety, tolerability and device deficiencies of zilucoplan (ZLP) in healthy adult participants
- Trial name
- NCT06511076
- Testing
- Zilucoplan
- Where
- Netherlands
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma SRL
Healthy
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
- Trial name
- NCT00834977
- Testing
- Amlodipine-benazepril 10 mg-20 mg capsules, Lotrel® 10 mg-20 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Study in Healthy Volunteers to Prove That 2 Rotigotine Patches From Different Manufacturing Processes 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 2 rotigotine transdermal patches from 2 different manufacturing processes.
- Trial name
- NCT00881894
- Testing
- Rotigotine transdermal patch
- Where
- Germany
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Healthy
A Study in Healthy People to See How Zongertinib is Taken up Into the Blood When Given as Tablets Made by Two Different Manufacturers
The main objective of this trial is to establish the bioequivalence of zongertinib tablet from manufacturer 1 (Test, T) compared with zongertinib tablet from manufacturer 2 (reference, R) following oral administration.
- Trial name
- NCT06360081
- Testing
- Zongertinib manufacturer 1, Zongertinib manufacturer 2
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pharmacokinetic Bioequivalence Study in Human Healthy Volunteers
Comparative, Pharmacokinetic and Pharmacodynamic Study of Subcutaneous Injections of INTP5 of Intas Pharmaceuticals Ltd., India Against Neulasta of Amgen Inc., USA in Healthy, Adult Human Subjects.
The study was an assessor-blind, balanced, randomized, two-treatment, two-period, single-dose, two-way crossover, comparative, pharmacokinetic (PK) and pharmacodynamic (PD) study of subcutaneous (SC) Pegfilgrastim injection (6…
- Trial name
- NCT04014062
- Testing
- INTP5, US Neulasta
- Where
- India
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Intas Pharmaceuticals, Ltd.
Chronic Idiopathic Constipation
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
- Trial name
- NCT03097861
- Testing
- Lubiprostone
- Where
- 67 sites in United States
- Volunteers
- 552 people
- Sponsor
- Sucampo Pharma Americas, LLC
Drug Use
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.
- Trial name
- NCT04982874
- Testing
- Furosemide 40 mg, Lasix® 40 mg Tablet
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Kimia Farma (Persero) Tbk
Healthy
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals…
- Trial name
- NCT00834197
- Testing
- Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Non-Fasting Conditions.
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840216
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Atopic Dermatitis
Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
The purpose of this study is to compare the safety and efficacy profiles of Watson Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America LLC's Elidel® (pimecrolimus) Cream, 1%, and to…
- Trial name
- NCT02791308
- Testing
- Pimecrolimus Cream 1% (Valeant), Vehicle cream, Pimecrolimus Cream, 1%
- Where
- 53 sites in United States
- Volunteers
- 587 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Brain Neoplasms, Malignant, Primary
Bioequivalence Study of Temozolomide in Patients With Primary Tumors of the Central Nervous System
The purpose of this crossover, single-dose, bioequivalence study is to compare the rate and extent of absorption of Temozolomide after the administration of the study product (Dralitem®, Monte Verde S.A.) and the reference…
- Trial name
- NCT02343081
- Testing
- Temozolomide
- Where
- 2 sites in Argentina
- Volunteers
- 24 people
- Sponsor
- Monte Verde SA
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC