Clinical trials: Bioequivalence
Healthy
Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00684723
- Testing
- Lovastatin 40 mg Tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Non-Fasted Conditions
The purpose of this study was to evaluate the relative bioavailability of a test formulation of norethindrone/ethinyl estradiol 0.4 mg/0.035 mg chewable tablets (Teva Pharmaceuticals, USA) compared to the reference listed…
- Trial name
- NCT01344369
- Testing
- Norethindrone/Ethinyl Estradiol, FEMCON® Fe
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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
Healthy
Bioequivalence of Empagliflozin and Metformin Given as a Fixed Dose Combination Compared to Single Tablets
The primary objective of this trial is to establish bioequivalence of two fixed dose combination (FDC) tablets (containing medium dose empagliflozin/500 mg metformin [Test 1] and low dose empagliflozin/500 mg metformin [Test 2])…
- Trial name
- NCT01844531
- Testing
- empagliflozin, metformin (Glucophage®), empagliflozin and metformin
- Where
- Germany
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Glimepiride 4 mg Tablets Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00835172
- Testing
- Glimepiride 4 mg Tablets, AMARYL® 4 mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Peer Review, Research
Fentanyl Patch Pharmacokinetics in Healthy Adults
The study to be performed will utilize already FDA-approved marketed products in healthy adults for the purpose to generate data for establishing rate of drug delivery comparisons between RLD (reference listed drug) Duragesic ®…
- Trial name
- NCT02531971
- Testing
- Intravenous fentanyl citrate, Duragesic®, Mylan generic fentanyl
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Healthy
A Study of Lanabecestat (LY3314814) in Healthy Participants
The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat.
- Trial name
- NCT02663128
- Testing
- Lanabecestat
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
Bioequivalence of Two Lispro Formulations
This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.
- Trial name
- NCT01133392
- Testing
- Insulin lispro A, Insulin lispro B
- Where
- Singapore
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Ondansetron HCl Orally Disintegrating Tablets Under Fasting Conditions
The objective of this study was to compare the relative bioavailability of the test formulation of Ondansetron HCl with the already marketed reference formulation Zofran ODT under fasting conditions in healthy, non-smoking adult…
- Trial name
- NCT00934180
- Testing
- Ondansetron, Zofran®
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Demonstration of Bioequivalence of Empagliflozin and Metformin Given in One Tablet Compared to the Intake of Single Tablets
The primary objective of this trial is to establish bioequivalence of two FDC tablets and the single tablets when administered together after a high fat high caloric meal.
- Trial name
- NCT01672788
- Testing
- Empagliflozin, Empagliflozin + Metformin, Metformin
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Arthritis, Rheumatoid
This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets.
It is a randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study of Meloxicam GSK 15 mg tablets manufactured by Savipharm J.S.Cc, Vietnam and Mobic® 15 mg…
- Trial name
- BA/BE: 250/12 (NCT01750931)
- Testing
- Meloxicam GSK 15mg, Mobic 15mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
To Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (80 mg) relative to the original OxyContin® (OXY) formulation (80 mg) in the fed state.
- Trial name
- NCT01101178
- Testing
- Reformulated OXY (oxycodone HCl), Original OxyContin® (OXY) (oxycodone HCl)
- Where
- United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Healthy
A Study to Determine the Fasting Bioequivalence of Reformulated OXY Tablets Manufactured at Two Different Facilities
The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10 mg) manufactured at the Totowa, NJ facility relative to the formulation (10 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101308
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
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
Healthy
Bioequivalence Study of Letrozole 2.5 mg Tablets
Bioequivalence
- Trial name
- NCT01084499
- Testing
- Femara (Sequence 1), Peratra (Sequence 1), Femara (Sequence 2)
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Healthy
90 mg Fluoxetine Hydrochloride Capsules Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 90 mg Fluoxetine Hydrochloride Capsules by Teva Pharmaceuticals, USA with that of 90 mg PROZAC WEEKLY® Capsules by Eli Lilly and Company…
- Trial name
- NCT01247285
- Testing
- Fluoxetine Hydrochloride, PROZAC WEEKLY®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Healthy
Azithromycin 600 Mg Tablets, Fed
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the relative bioequivalence of a test azithromycin formulation (TEVA Pharmaceuticals USA) to an equivalent oral dose of the commercially…
- Trial name
- NCT00834132
- Testing
- Azithromycin 600 mg Tablet, Zithromax® 600 mg Tablet
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Chemotherapy-Induced Nausea and Vomiting
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
- Trial name
- NCT00971633
- Testing
- Comparator: Treatment A (Zofran, ondansetron), Comparator: Treatment B (Zofran, ondansetron), Comparator: Treatment C (Zofran, ondansetron)
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
Ramipril 10 mg Capsule in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fasting conditions.
- Trial name
- NCT00828321
- Testing
- Ramipril 10 mg capsule, Altace® 10 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA