Clinical trials: Bioequivalence
Allergic Contact Dermatitis
Bioequivalence of Ethylenediamine Dihydrochloride Study
The purpose of this study is to compare the allergen ethylenediamine dihydrochloride when prepared using methylcellulose versus preparation using polyvinylpyrrolidone.
- Trial name
- NCT01798589
- Testing
- Ethylenediamine dihydrochloride allergen patch
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Allerderm
Insomnia
A Bioequivalence and Food Effect Study of SEP-190 in Japanese Healthy Subjects (Study SEP 190-102)
The purpose of this study is to investigate and evaluate the bioequivalence and food effect of SEP 190-102 in Japanese healthy subjects by assessing the pharmacokinetics parameters.
- Trial name
- NCT01055834
- Testing
- Eszopiclone 3 mg, Eszopiclone 1 mg
- Where
- Japan
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Eisai Co., Ltd.
Healthy
5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 5 mg Glipizide/500 mg Metformin Hydrochloride Tablets manufactured by TEVA Pharmaceutical Industries, Ltd., and distributed by TEVA…
- Trial name
- NCT00834587
- Testing
- 5 mg/500 mg METAGLIP™ Tablets, 5 mg/500 mg Glipizide Metformin Hydrochloride Tablets
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
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 (80 mg) manufactured at the Totowa, NJ facility relative to the formulation (80 mg) manufactured at the Wilson, NC facility in the fasted…
- Trial name
- NCT01101321
- Testing
- Reformulated OXY (Totowa) (oxycodone HCl), Reformulated OXY (Wilson) (oxycodone HCl)
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Purdue Pharma LP
Glaucoma, Open Angle or Ocular Hypertension
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM
- Trial name
- NCT03896633
- Testing
- brinzolamide 1% ophthalmic suspension, Azopt 1%
- Where
- United States
- Volunteers
- 637 people
- Sponsor
- Bausch & Lomb Incorporated
Healthy
Leflunomide 20 mg Tablets Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 20 mg Leflunomide Tablets by TEVA Pharmaceuticals Industries, Ltd. with that of 20 mg ARAVA™ Tablets by Aventis Pharmaceuticals, Inc.
- Trial name
- NCT00834418
- Testing
- Leflunomide 20 mg Tablets, ARAVA™ 20 mg Tablets
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Terbinafine HCl 250 mg Tablet Formulations Under Non-Fasting Conditions
The Purpose of this study os to evaluate the relative bioavailability of the test formulation of terbinafine tablets with an already marketed reference formulation Lamisil® (Novartis Pharmaceuticals), under post-prandial…
- Trial name
- NCT00833664
- Testing
- Terbinafine HCl 250mg tablets, Lamisil® 250 mg Tablets
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Cefdinir Capsules 300 mg, Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 300 mg Cefdinir Capsules manufactured and distributed by TEVA pharmaceuticals USA with that of OMNICEF® Capsules by CEPH International…
- Trial name
- NCT00835484
- Testing
- Cefdinir Capsules 300 mg, OMNICEF® 300 mg
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy Volunteers
Food Effect and Bioequivalence Study of Simufilam Tablets in Healthy Volunteers
This study will compare the pharmacokinetics of the Phase 3 simufilam 100 mg oral tablet when taken fasted versus following a high-fat or low-fat meal.
- Trial name
- NCT04932655
- Testing
- simufilam
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cassava Sciences, Inc.
Contraception
A Bioequivalence Study of IMPLANON and Radiopaque IMPLANON (34528)(P05720)
The primary purpose of this study is to demonstrate the bioequivalence of IMPLANON and Radiopaque IMPLANON.
- Trial name
- NCT00620464
- Testing
- Radiopaque Implanon, Implanon (etonogestrel implant)
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Ovarian Cancer, Breast Cancer
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
- Trial name
- NCT05258747
- Testing
- Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Sandoz
Hereditary Tyrosinemia, Type I
Bioequivalence Study of Two Oral Nitisinone Formulations to Treat Hereditary Tyrosinemia (HT-1)
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1) and Nitisinone 10 mg Tablets 'Baked' for 6 months @ 40°C/75% RH (Test Product 2) are bioequivalent to the reference product Orfadin 10 mg…
- Trial name
- NCT02750345
- Testing
- Nitisinone, Nitisinone Baked Tablet, Orfadin
- Where
- South Africa
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Diabetic Foot
BE Study of Metformin GSK 500mg
A randomized, balanced, open label, crossover, two period, two treatment, two sequence, single dose, oral bioequivalence study under fasting condition. It is a pivotal study.
- Trial name
- BA/BE 173/11 (NCT01710527)
- Testing
- Metformin 500mg, Glucophage 500mg
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Cilostazol 100 mg Tablet Formulations Under Fasting Conditions
The objective of this randomized, single-dose, two-way evaluation is to compare the bioequivalence of a test cilostazol formulation to an equivalent oral dose of the commercially available cilostazol in a test population of 36…
- Trial name
- NCT00838630
- Testing
- Cilostazol 100 mg tablets, Pletal® 100 mg tablets
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants.
- Trial name
- NCT04314037
- Testing
- Cesol (Test), Biltricide (Reference)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Healthy Volunteers
A Study of 2 Different Formulations of Insulin Lispro in Healthy Participants
The study involves 4 injections of insulin lispro and its purpose is to: Determine if 2 formulations of insulin lispro are treated by the body in a similar way.
- Trial name
- NCT02111083
- Testing
- Insulin Lispro
- Where
- Singapore
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
This Study Tests Whether Taking the Medicines Empagliflozin, Linagliptin, and Metformin Together in 1 Pill is the Same as Taking Them in Separate Pills. The Study is Done in Healthy Men and Women and Measures the Amount of Each Medicine in the Blood
To establish the bioequivalence of one fixed dose combination (FDC) tablet of empagliflozin/linagliptin/metformin extended release (XR) versus the free combination of empagliflozin tablet, linagliptin tablet, and metformin XR…
- Trial name
- NCT03259490
- Testing
- Empagliflozin/linagliptin/metformin HCl, Empagliflozin, Linagliptin
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men…
- Trial name
- NCT03456960
- Testing
- TAK-438ASA, TAK-438, Aspirin
- Where
- Japan
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Takeda
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04400682)
- Testing
- FAVIRA 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novelfarma Ilaç San. ve Tic. Ltd. Sti.
Healthy
Glucophage Extended Release (GXR) China Bioequivalence Study (Nantong - Darmstadt)
The study will assess the bioequivalence between single doses of GXR manufactured in Merck Nantong China (test drug) and GXR manufactured in Merck Darmstadt Germany (reference drug) under fed and fasted state in healthy…
- Trial name
- NCT03566810
- Testing
- Test GXR, Reference GXR
- Where
- China
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany