Clinical trials: Therapeutic Equivalency
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
Type 2 Diabetes
Human Bioequivalence Test of Liraglutide Injection
To evaluate the bioequivalence of The liraglutide injection produced by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and Victoza® produced by Novo Nordisk (China) Pharmaceutical Co., Ltd for single dose in healthy subjects,so…
- Trial name
- NCT05029076
- Testing
- Liraglutide injection, Victoza
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation…
- Trial name
- NCT01262989
- Testing
- Test formulation, Reference formulation
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
Study of MN-166 (Ibudilast) Extended Release Tablet Formulations Compared With Capsules in Healthy Volunteers
To compare the bioavailability and pharmacokinetic profiles of two different formulations MN-166 50mg, extended release (ER) tablets with MN-166 10mg capsules in a single-dose regimen in healthy volunteers
- Trial name
- NCT03533387
- Testing
- MN-166
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- MediciNova
Healthy
Rivastigmine Bioequivalence Trial With Multiple Application of Transdermal Patches (13.3mg/24h)
The present clinical trial will be conducted in order to compare the bioavailability of rivastigmine and to assess bioequivalence at steady-state of the Test product RID-TDS 13.3 mg/24 h (Luye Pharma AG, Germany) and the marketed…
- Trial name
- NCT05853341
- Testing
- RID-TDS 13.3 mg/24 h, Exelon® 13.3 mg/24 h
- Where
- Germany
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy
Bioavailability Study of Amlodipine Besylate/Atorvastatin Calcium Tablets 10/80 mg Under Fed Condition
This study is to assess the bioequivalence between Amlodipine besylate/Atorvastatin calcium Tablets 10mg/80mg of Dr. Reddy's Laboratories Limited, India and CADUET® (amlodipine besylate and atorvastatin calcium) tablets 10mg/80mg…
- Trial name
- NCT02292069
- Testing
- Amlodipine besylate/Atorvastatin calcium
- Where
- India
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
GXR RM China BE Study (Darmstadt - Jiangsu)
The purpose of this study is to assess Bioequivalence (BE), pharmacokinetics (PK), safety and tolerability following single oral dose administrations between a Glucophage Extended Release, Reduced Mass (Glucophage XR RM)…
- Trial name
- NCT05463094
- Testing
- Test Glucophage® XR, Reference Glucophage® XR
- Where
- Germany
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
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