Clinical trials: Therapeutic Equivalency
Healthy
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).
- Trial name
- NCT00845663
- Testing
- Certolizumab pegol
- Where
- France
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Glaucoma, Open-Angle
Bioequivalence Study With Clinical Endpoint Comparing Bimatoprost Ophthalmic Solution 0.01% to LUMIGAN® In The Treatment of Chronic Open-Angle Glaucoma
This is a randomized, double-masked, two-treatment, single-period, parallel design, multiple dose at multiple clinical trial sites designed to demonstrate bioequivalence with clinical endpoint in subjects with chronic open-angle…
- Trial name
- Glaucoma (NCT04890106)
- Testing
- Test - Bimatoprost 0.01% Ophthalmic Solution, Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)
- Where
- 9 sites in United States
- Volunteers
- 310 people
- Sponsor
- Mankind Pharma Limited
Healthy
Clarithromycin 500 mg Tablets Under Non-Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Clarithromycin Tablets with that of 500 mg BIAXIN® Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects…
- Trial name
- NCT00836706
- Testing
- clarithromycin, BIAXIN®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Contraception, Ovulation Inhibition
Bioequivalence Study: 3 mg Estradiol Valerate (EV) With and Without Levomefolate Calcium
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet…
- Trial name
- NCT01031355
- Testing
- Estradiol Valerate (EV) / Levomefolate Calcium (BAY98-7078), Estradiol Valerate (EV) (BAY86-4980), Levomefolate Calcium (BAY86-7660)
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Food Study of Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg and Macrobid® Capsules 100 mg
The objective of this study was to investigate the bioequivalence of Mylan's nitrofurantoin monohydrate/macrocrystals capsules to Procter \& Gamble's Macrobid® capsules following a single, oral 100 mg (1 x 100 mg) dose under fed…
- Trial name
- NCT00649285
- Testing
- Nitrofurantoin Monohydrate/Macrocrystals Capsules 100 mg, Macrobid® Capsules 100 mg
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
A Relative Bioavailability Study of Finasteride 5 mg Tablets Under Fed Conditions
The purpose of this study is to compare the rate and extent of absorption of Actavis Group hf, Iceland, finasteride and Merck \& Co. Inc., U.S.A. (Proscar), finasteride, administered as a 1 x 5 mg tablet, under fed conditions.
- Trial name
- NCT00871247
- Testing
- Finasteride 5 mg Tablet, single dose, Proscar® 5 mg Tablet, single dose
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Overweight
A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
The purpose of this study is to determine whether a new dosage form and dose of orlistat is equivalent to the currently marketed form.
- Trial name
- NCT01550926
- Testing
- 120 mg orlistat, 60 mg orlistat, orlistat experimental dose
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Sumatriptan Succinate 100 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 100 mg Tablets under fed conditions.
- Trial name
- NCT00846885
- Testing
- Sumatriptan Succinate, Imitrex®
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects
The purpose of this study is to demonstrate bioequivalence between the test drug product, fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50 mg/mL.
- Trial name
- NCT02795039
- Testing
- Fulvestrant
- Where
- 3 sites in Canada
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi
Mild Persistent Asthma
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.
- Trial name
- NCT02584257
- Testing
- methacholine chloride, ProAir HFA, Lupin albuterol HFA MDI
- Where
- 17 sites in United States
- Volunteers
- 217 people
- Sponsor
- Lupin, Inc.
Atopic Dermatitis
Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis
To establish the bioequivalence between test drug, Pimecrolimus Cream, 1% with that of reference listed drug, Elidel® (pimecrolimus) Cream 1%, in the treatment of mild to moderate Atopic Dermatitis.
- Trial name
- NCT03107611
- Testing
- Pimecrolimus Cream, 1%
- Where
- 27 sites in United States, Dominican Republic and 1 more
- Volunteers
- 654 people
- Sponsor
- Mylan Inc.
Healthy Subjects
Desogestrel Tablets (0.075 mg) Relative to Originator Desogestrel Tablets (0.075 mg)
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
- NCT06233084
- Testing
- Desogestrel-Test product, Desogestrel-Reference product
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Healthy
Bioequivalence Study of Ropinirole Hydrochloride ER Tablets 2 mg Under Fed Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, oral bioequivalence study.
- Trial name
- NCT01627847
- Testing
- Ropinirole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Bioequivalence of Telmisartan / HCTZ of Fixed Dose Combination Compared to Its Monocomponents in Healthy Male Volunteers
To establish the bioequivalence of fixed dose combination of 40 mg telmisartan / 12.5 mg HCTZ vs. its monocomponents
- Trial name
- NCT02262598
- Testing
- Telmisartan, Hydrochlorthiazide (HCTZ), Telmisartan/HCTZ fixed dose
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Adults
A Bioequivalence Study of Two Formulations Lamotrigine 100 mg Tablets and Lamictal 100 mg Tablets in Healthy Adult Volunteers Under Fasting Conditions
This is an open-labeled, randomized, crossover, two-period, single-center, comparative study, where each participant will be randomly assigned to the reference (Lamictal, 100 mg tablets) or the test (Lamotrigine, 100 mg tablets)…
- Trial name
- NCT03898011
- Testing
- Lamotrigine, Lamictal
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivalence Study of Atorvastatin Calcium Tablets, 80 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to compare and evaluate the single-dose oral bioavailability and to monitor the safety of subjects.
- Trial name
- NCT01645449
- Testing
- Atorvastatin Calcium Tablets, 80 mg
- Where
- Germany
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes
To Demonstrate the Relative Bioequivalency Comparing Geneva's 10 mg Glipizide Tablets To Roerig's 10 mg Glucotrol Tablets
To demonstrate the relative bioequivalency comparing Geneva's 10 mg Glipizide tablets to Roerig's 10 mg Glucotrol tablets.
- Trial name
- NCT00946504
- Testing
- Glipizide 10 mg Tablets (Geneva Pharmaceutical, Inc.), Glucotrol 10 mg Tablets (Roerig Pharmaceutical, Inc.)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sandoz
Diabetes, Healthy
Comparison of Two Insulin Detemir Formulations in Healthy Volunteers
This trial is conducted in Europe. The aim of this trial is to compare two formulations of insulin detemir containing an isotonic agent in healthy volunteers.
- Trial name
- NCT01498926
- Testing
- insulin detemir
- Where
- United Kingdom
- Volunteers
- 34 people
- Sponsor
- Novo Nordisk A/S
Healthy Volunteer
Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy…
- Trial name
- NCT07300033
- Testing
- Liquid Metformin 100 mg/mL, Liquid Metformin 250 mg/mL, Metformin Immediate-Release Tablet
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Healthy
Evaluating the Bioequivalence of HIP1403, HGP0919
The purpose of this study is to investigate the bioequivalence after administration of HIP1403 and HGP0919 in healthy male volunteers
- Trial name
- NCT02473900
- Testing
- HIP1403, HGP0919
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
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