Clinical trials: Therapeutic Equivalency
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
Pain, Head, Pain, Acute
Single-Dose Bioavailability Study of Two Formulations of Ibuprofen and Pseudoephedrine Hydrochloride Tablets
Evaluation of the comparative bioavailability between two oral formulations containing ibuprofen 200 mg and pseudoephedrine 30 mg after a single dose in healthy subjects under fasting conditions.
- Conditions
- Pain, Head, Pain, Acute, Pain, Back, Fever
- Trial name
- NCT03429738
- Testing
- Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets, RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets
- Where
- Canada
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Institut für Pharmakologie und Präventive Medizin
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
Healthy
Bioequivalence Study of Generic GPO Ritonavir Versus Norvir®
To establish bioequivalence of ritonavir generic capsule, with Norvir® as reference drug.
- Trial name
- NCT00477126
- Testing
- GPO ritonavir versus Norvir
- Where
- Thailand
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
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"
Healthy
A Study of Two Formulations of Ixekizumab in Healthy Participants
The purpose of this study is to compare two different formulations of ixekizumab. One formulation (Reference) is approved by the Food and Drug Administration (FDA) and one formulation (Test) is not approved.
- Trial name
- NCT04259346
- Testing
- Ixekizumab
- Where
- 4 sites in United States
- Volunteers
- 245 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Epilepsy
Lamotrigine Bioequivalence Study to Compare Dispersible Tables With Compressed Tablets in China
It is an open-label, randomised, single dose, two-sequence cross-over study. Twenty-four eligible, healthy, Chinese male subjects will be enrolled after providing written informed consent.
- Trial name
- NCT01357902
- Testing
- Lamotrigine
- Where
- Hong Kong
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Subjects
Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets
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
- NCT06289881
- Testing
- Sildenafill-Test product, Sildenafill-Reference product
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
The primary object of this study was to evaluate the relative bioavailability of the test formulation of metronidazole vaginal gel with the already marketed reference formulation MetroGel-Vaginal Gel® in healthy adult female…
- Trial name
- NCT01020877
- Testing
- Metronidazole
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Study of Sumatriptan Succinate Tablets 100 mg to Imitrex® Tablets 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's sumatriptan succinate 100 mg tablets to GSK's Imitrex® 100 mg tablets following a single, oral 100 mg (1 x 100 mg) dose administration under fasting…
- Trial name
- NCT00648466
- Testing
- Sumatriptan Succinate Tablets 100 mg, Imitrex® Tablets 100 mg
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Fasting Study of Azithromycin Tablets 600 mg to Zithromax® Tablets 600 mg
The objective of this study was to investigate the bioequivalence of Mylan's azithromycin 600 mg tablets to Pfizer's Zithromax® 600 mg tablets following a single, oral 600 mg (1 x 600 mg) dose administered under fasting…
- Trial name
- NCT00650273
- Testing
- Azithromycin Tablets 600 mg, Zithromax® Tablets 600 mg
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
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