Clinical trials: Therapeutic Equivalency
Opioid Induced Constipation
Open Label, Healthy Volunteers, Bioequivalence Study With Naloxegol
The purpose of this study is to demonstrate the Bioequivalence, assess food administration on the Pharmacokinetics with naloxegol.
- Trial name
- NCT01623609
- Testing
- Naloxegol
- Where
- United Kingdom
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hypertension
Bioequivalence Study of Doxazosin 4 Mg Orally-Disintegrating Tablet With Or Without Water To Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
To test bioequivalence of Doxazosin 4 Mg Orally-disintegrating Tablet with Or Without Water to Doxazosin 4 Mg Japanese Marketed Immediate Release Tablet Under Fasted Condition
- Trial name
- NCT01389609
- Testing
- Doxazosin 4 mg Japanese marketed IR tablet, Doxazosin 4 mg ODT with water, Doxazosin 4 mg ODT without water
- Where
- Japan
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
Bioequivalence Study of Rivaroxaban 20 mg Film-coated Tablets
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fed conditions which included 28 healthy adult male and female subjects.
- Trial name
- NCT06558045
- Testing
- Rivaroxaban 20 mg film-coated tablet, Xarelto 20 mg film-coated tablet
- Where
- Indonesia
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Hypertension
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet Under Fasting and Fed
To Demonstrate the Relative Bioequivalence of Lisinopril 1 x 40 mg Tablet under Fasting and Fed.
- Trial name
- NCT00883506
- Testing
- Lisinopril 40 mg Tablet (Zestril) under fed conditions., Lisinopril 40 mg Tablet under fasting conditions., Lisinopril 40 mg Tablet under fed conditions.
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Bioequivalence Study of Eszopiclone Tablets, 3 mg Under Fed Conditions
This is an open-label, randomized, two-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fed conditions.
- Trial name
- NCT02322658
- Testing
- Eszopiclone Tablets 3 mg
- Where
- India
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Food Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg
The objective of this study was to investigate the bioequivalence of Mylan's midodrine HCl 5 mg tablets to Roberts ProAmatine® 5 mg tablets following a single, oral 5 mg (1 x 5 mg) dose administration under fed conditions.
- Trial name
- NCT00648440
- Testing
- Midodrine HCl Tablets 5 mg, ProAmatine® Tablets 5 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Solid Tumor
An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition
An open-label, randomized, single-dose, two-way crossover bioequivalence study to compare two strengths (10 mg and 20 mg) of IMP4297 capsules in healthy Chinese subjects under fed condition
- Trial name
- NCT05391048
- Testing
- IMP4297(20mg), IMP4297(10mg)
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Impact Therapeutics, Inc.
Primary Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Healthy
Bioequivalence Study Of Phenytoin Suspension Versus Epamin® In 34 Healthy Volunteers.
Mexican healthy volunteers will receive the current form of the drug (under the name of Epamin) as well as Pfizer's compound (Phenytoin). Bioequivalence will be tested.
- Trial name
- NCT01122940
- Testing
- Epamin: Reference Drug, Phenytoin: Study Drug
- Where
- Mexico
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Bioequivalence
Norethindrone/Ethinyl Estradiol 0.4 mg/35 Mcg Chewable Tablets Under Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of 0.4 mg/35 mcg Norethindrone and Ethinyl Estradiol Chewable Tablets by Teva Pharmaceuticals, USA with that of 0.4 mg/35 mcg Ovcon® 35 Fe Chewable…
- Trial name
- NCT01340625
- Testing
- Norethindrone/Ethinyl Estradiol, Ovcon® 35 Fe
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Female Contraception, Contraception
Bioequivalence Study of the Oral Contraceptive Tablet Containing Norgestimate (NGM)/Ethinyl Estradiol (EE) With or Without Folic Acid in Healthy Women.
The purpose of the study is to determine the bioequivalence of NGM and EE in 2 formulations of 250 mcg NGM/35 mcg EE, 1 without folic acid and 1 containing 400 mcg folic acid.
- Conditions
- Female Contraception, Contraception, Therapeutic Equivalency, Pharmacokinetics
- Trial name
- NCT00709189
- Testing
- Norgestimate/Ehinyl Estradiol; Folic acid.
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hypercholesterolemia
Bioequivalence Study On Pediatric Appropriate Formulation
To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.
- Trial name
- NCT00777517
- Testing
- Lipitor, Atorvastatin pediatric formulation
- Where
- Singapore
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Subjects
A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles.
- Trial name
- NCT07235189
- Testing
- Bempedoic acid, Ezetimibe, Atorvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Safety, Pharmacokinetics
Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects
This study is to investigate whether anastrozole ODF is bioequivalent with Arimidex tablet after a single oral administration of each anastrozole formulation.
- Trial name
- NCT01568281
- Testing
- Anastrozole ODF, Arimidex tablet
- Where
- Japan
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Comparison of Two Formulations of Androxal
To determine and compare the pharmacokinetics (PK) of a single dose of each of two formulations Androxal
- Trial name
- NCT01984398
- Testing
- 12.5 mg Androxal Formulation A, 12.5 mg Androxal Formulation B, 25 mg Androxal Formulation A
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Healthy Subjects
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid / Ezetimibe, and Atorvastatin
Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles.
- Trial name
- NCT07268625
- Testing
- Bempedoic acid, Ezetimibe, Atorvastatin
- Where
- Portugal
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo
Healthy
A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy…
- Trial name
- NCT04230252
- Testing
- Acetaminophen
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Healthy Male Chinese Volunteers
A Study to Investigate the Bioequivalence of Lacosamide 200mg Administered as Intravenous Solution and Oral Tablet in Healthy Chinese Male Subjects
The purpose of this study is to assess the bioequivalence of a 200 mg single dose Lacosamide (LCM) intravenous (iv) solution with a 200 mg single dose LCM oral tablet in healthy Chinese male subjects.
- Trial name
- NCT03204474
- Testing
- Lacosamide (LCM) tablet, Lacosamide (LCM) solution for infusion
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Healthy Adults
A Study to Compare the Amount of Two Forms of Tafamidis in the Blood of Healthy Adults Under Fasting Conditions
The purpose of this clinical trial is to compare the blood tafamidis concentration of healthy adult participants after taking two different forms of tafamidis by under fasted conditions.
- Trial name
- NCT07587697
- Testing
- Tafamidis
- Where
- Japan
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland)
Comparative randomized, single dose, two-way crossover open-label study to determine the bioequivalence of Sofosbuvir from Heterosofir 400 mg F.C.T (Pharmed Healthcare Co., Egypt) versus Sovaldi 400 mg F.C.T (Gilead Sciences…
- Trial name
- NCT02491450
- Testing
- Heterosofir, Sovaldi
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
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