Clinical trials: Therapeutic Equivalency
Healthy Volunteer, Healthy Adult Participants
A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI). The study will comprise 2 study periods of 3 weeks each.
- Trial name
- NCT07782775
- Testing
- Efgartigimod PH20 SC via PFS, Efgartigimod PH20 SC via AI
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- argenx
Pomalidomide Bioequivalence Study in Healthy Volunteers
Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects
This study evaluated the bioequivalence and tolerability of a test pomalidomide formulation (Xetrane® 4 mg hard capsule) compared with the reference formulation (Imnovid® 4 mg hard capsule) in healthy male subjects under fasting…
- Trial name
- PRO-BEQ-PMD-00 (NCT07694011)
- Testing
- Xetrane® (Pomalidomide) 4 mg Hard Capsule, Imnovid® (Pomalidomide) 4 mg Hard Capsule
- Where
- Chile
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Knight Therapeutics (USA) Inc
Healthy
Study to Assess the Bioequivalence of Two Batches of Tamsulosin Hydrochloride in Healthy Male Subjects
The objective of this study is to determine the bioequivalence of two batches of Flomax® 0.4 mg capsules in healthy male subjects.
- Trial name
- NCT02266511
- Testing
- Flomax®, Norman II facility, Flomax®, Nishine facility
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Acute Coronary Syndrome
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)
The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.
- Trial name
- NCT01358344
- Testing
- Pantoprazole, SCH 530348 (high percentage), SCH 530348 (standard percentage)
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fasting Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fasted conditions.
- Trial name
- NCT01222975
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study in Healthy People to Test How Zongertinib is Taken up in the Body When Given as Tablets Made by Two Different Manufacturers With or Without Food
The main objective of this trial is to establish the bioequivalence of Zongertinib tablets from two different manufacturers following oral administration.
- Trial name
- NCT07789028
- Testing
- Zongertinib, Formulation A, reference product, Zongertinib Formulation B, test product
- Where
- Germany
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer
A Bioequivalence Study Of AG-013736 Tablets Under Fed Conditions In Healthy Volunteers
The purpose is to show that 5 mg Form IV tablet of AG-013736 produces similar drug concentrations in plasma compared to 5 mg Form XLI tablet of AG-013736 after oral dosing under fed conditions.
- Trial name
- NCT01020136
- Testing
- AG-013736
- Where
- Singapore
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer
Pain
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
The primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.
- Trial name
- NCT01769677
- Testing
- 90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Healthy
Bioequivalence Study of Losartan Potassium and Hydrochlorothiazide (100 mg / 25 mg Tablet) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Hyzaar® (100 mg / 25 mg Tablet) [Reference Formulation, Merck & Co., Inc., USA] in Healthy Human Volunteers Under Fasting Conditions.
Objective: to compare the single dose bioavailability of Torrent's Losartan Potassium and Hydrochlorothiazide Tablets 1 × 100/25mg and Hyzaar® Tablets 1 × 100/25mg of Merck \& Co., Inc.
- Trial name
- NCT01218711
- Testing
- Losartan Potassium and Hydrochlorothiazide Tablets
- Sponsor
- Torrent Pharmaceuticals Limited
Chronic Obstructive Pulmonary Disease
A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co.
- Trial name
- NCT06326671
- Testing
- Tiotropium Bromide Inhalation Powder, Spiriva HandiHaler
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy Subjects
Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Relative to Originator
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233201
- Testing
- Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Test product, Sitagliptin and Metformin Hydrochloride Tablets 50 mg/500 mg Reference product
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study for Lamotrigine Tablets 200 mg Under Fed Condition
This is an single dose,two-way, crossover, oral bioequivalence study.
- Trial name
- NCT01513681
- Testing
- Lamotrigine, Lamictal®
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Postmenopausal Osteoporosis
Bioequivalence Study of SAL001 and FORSTEO in Healthy Chinese Adults
This is a single-center, randomized, open label, single-dose, the original drug controlled, crossover design, two sequence, two periods, Phase Ⅰclinical study.
- Trial name
- NCT04747392
- Testing
- SAL001, FORSTEO
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Healthy
Glucophage Immediate Release (GIR) China Bioequivalence Study
The study will assess the bioequivalence between single doses of glucophage immediate release (GIR) test tablets and GIR reference tablets under fed and fasted state in healthy subjects.
- Trial name
- NCT03393208
- Testing
- Test GIR, Reference GIR
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Actinic Keratosis (AK)
Bioequivalence Study to Compare Sol-Gel Technologies' 5-FU Cream With Efudex® (5-FU) Cream
To compare the relative efficacy and safety and of 5-FU Cream to the marketed formulation Efudex® (5-FU) Cream, and to demonstrate the superior efficacy of the two active formulations over that of the Vehicle Control Cream, in…
- Trial name
- NCT03727074
- Testing
- 5-FU Cream, Efudex®, Vehicle
- Where
- United States
- Volunteers
- 462 people
- Sponsor
- Sol-Gel Technologies, Ltd.
Dermatitis, Contact
Clinical Evaluation of T.R.U.E. TEST® Fragrance Mix and Thimerosal Allergens:Bioequivalence of PVP Formulations
Open, prospective, multi-center study to evaluate the bioequivalence of povidone (PVP) formulations of 2 T.R.U.E. TEST allergens: fragrance mix and thimerosal.
- Trial name
- NCT00612768
- Testing
- TRUE Test allergens Fragrance Mix and Thimerosol
- Where
- 4 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Allerderm
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
Bioavailability/Bioequivalence Study Between Lacosamide Tablet and Solution for Infusion in Healthy Japanese Subjects
This study will be conducted to compare the pharmacokinetics of Lacosamide (LCM) following a single 30-minute or 60-minute iv infusion of LCM 200 mg with those following a single oral dose of LCM 200 mg in healthy Japanese…
- Trial name
- NCT01986608
- Testing
- Lacosamide infusion, Lacosamide oral
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- UCB Pharma SA
Prostatic Hyperplasia
A Study Assessing a Range of Formulations of the Fixed Dose Combination Product Containing Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) to Find a Formulation Which is Bioequivalent to Harnal-D Tablets (Tamsulosin Hydrochloride, 0.2mg) in Healthy Male Subjects From North East Asia
This study is an open-label, randomized, single dose, multi-stage, cross-over study in healthy male subjects of North East Asian ancestry.
- Trial name
- NCT01495026
- Testing
- Dutasteride (0.5mg, fasted state), Dutasteride (0.5mg, fed state), Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pharmacokinetics
Fasted Bioequivalence Study of 2 Olanzapine Film-coated Tablets, 5 mg, in Healthy, Adult Male and Female Subjects.
This study was designed to assess the bioequivalence of Olanzapine tablets of two different manufacturers and to investigate the safety and tolerability of Olanzapine tablets of two different manufacturers.
- Trial name
- NCT05123976
- Testing
- Olanzapine film-coated tablets 5 mg (JSC Farmak, Ukraine), Zyprexa® coated tablets 5 mg (Eli Lilly, Nederland B V)
- Where
- Czechia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
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