Clinical trials: Therapeutic Equivalency
Healthy
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting…
- Trial name
- NCT07610005
- Testing
- Varegacestat Reference Formulation, Varegacestat Test Formulation A, Varegacestat Test Formulation B
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Hepatitis C Infection
A Bioequivalence Study of Daclatasvir Tablets and Bioavailability Studies of Daclatasvir and Asunaprevir
Grps 1, 2, 3 "This study will be testing the performance of ASV and DCV pediatric chewable tablets. Grp #4 The purpose of this group is to support the marketing authorization of a DCV 90-mg tablet
- Trial name
- NCT02323594
- Testing
- Daclatasvir, Asunaprevir
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Clinical Bioequivalence Study on Two Lisinopril Tablets 20mg Formulations
The objective of the study is to compare the bioavailability of a generic product of lisinopril with that of a reference product when administered to healthy volunteers under fasting condition.
- Trial name
- NCT03599466
- Testing
- BF-Lisinopril Tablets 20mg, Zestril Tab 20mg
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
Healthy
Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting Conditions
The purpose of this study is to assess the bioequivalence between Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's and Depakote ER 500 mg Tablets of Abbott Laboratories in healthy, adult, human subjects, under fasting…
- Trial name
- NCT01581775
- Testing
- Divalproex Sodium
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes
Bioequivalence Study of Empagliflozin Tablet in Healthy Participants.
Bioequivalence Study of Empagliflozin Tablets and Jardiance® Under Fasting and Fed Conditions in Chinese Healthy Volunteers.
- Trial name
- NCT03771781
- Testing
- Empagliflozin Tablets, Empagliflozin Tab 25 MG
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Chemotherapy-induced Nausea and Vomiting, Prophylaxis
Evaluate Bioequivalence of Palonosetron (0.25mg/5mL)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of palonosetron after intravenous administration of palonosetron in healthy volunteers under fasting conditions.
- Trial name
- NCT04585412
- Testing
- Palonosetron
- Where
- Taiwan
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Bioequivalence
Bioequivalence Study of Two Formulations of Clopidogrel Film-coated Tablets 75 mg in Healthy Male Subjects Under Fasting Conditions
This is an open-labeled, randomized, four period, single-center, crossover, full replicative, comparative study, where each participant will be randomly assigned to the reference (Plavix®, 75 mg film-coated tablets) or the test…
- Trial name
- NCT05934799
- Testing
- Clopidogrel film-coated tablet 75 mg, Plavix® film-coated tablet 75 mg
- Where
- Russia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy
Bioequivalence of Alprazolam Sublingual vs Oral Tablets
This study tests the assumption that the bioavailability of alprazolam from a new sublingual formulation is the same as that from a standard orally administered tablet.
- Trial name
- NCT00860119
- Testing
- alprazolam sublingual tablet, alprazolam oral tablet
- Where
- India
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy Volunteers
A Study Comparing Blood Levels After Single-Dose Administration Of Artesunate Sachets (Pfizer) Versus Single-Dose Administration Of Arsuamoon® Tablets (Guilin-China) In Healthy Subjects
The primary objective of the study is to determine bioequivalence of 50 mg (2x25 mg) Artesunate Sachet (Pfizer) versus 50 mg (1x50 mg) tablet, Arsuamoon® (Guilin China) which is the World Health Organization Reference standard…
- Trial name
- NCT00875030
- Testing
- artesunate sachets, Arsuamoon
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pfizer
Epilepsy
Characterization of Epilepsy Patients BEEP 2b
Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products.
- Trial name
- BEEP2b (NCT02707965)
- Testing
- Oxcarbazepine (brand name vs generic drugs), Divalproex Sodium (brand name vs generic drugs), Carbamazepine (brand name vs generic drugs)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Food and Drug Administration (FDA)
Nutritional and Metabolic Diseases
Adverse Events in Pharmaceutical Bioequivalence Study of Two Formulations of Metformine Hydrochloride 500 mg
The objective is evaluate, in healthy volunteers, the bioavailability of two products containing metformine 500 mg to determine if they are bioequivalent and identify the occurrence of adverse events.
- Trial name
- NCT01367054
- Testing
- Metformin, Glifage
- Where
- Brazil
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Biocinese
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
Acne Vulgaris
Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris
To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.
- Trial name
- NCT03650361
- Testing
- Adapalene Gel 0.3%, Differin 0.3% Topical Gel
- Where
- 10 sites in United States, Belize
- Volunteers
- 755 people
- Sponsor
- Aleor Dermaceuticals Limited
Healthy Subjects
Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects
The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy…
- Trial name
- NCT07364669
- Testing
- Insulex® R (soluble human insulin, biosimilar), Humulin® R (soluble human insulin, biosimilar)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Laboratorios Pisa S.A. de C.V.
Healthy
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. DE C.V.
- Trial name
- NCT01151345
- Testing
- TILACEM, ANGIOTROFIN
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chemotherapy-Induced Nausea and Vomiting
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.
- Trial name
- NCT00972595
- Testing
- ondansetron clinical trial formulation, ondansetron marketed formulation
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Study of Fixed Dose Combination of Macitentan/Tadalafil (10 mg/20 mg) Compared to the Reference Free Combination of Macitentan and Tadalafil in Healthy Adult Participants
The purpose of this study is to demonstrate bioequivalence on the primary pharmacokinetic (PK) parameters between macitentan and tadalafil administered as a fixed dose combination (FDC) (test) of macitentan/tadalafil and the co…
- Trial name
- NCT05236231
- Testing
- Macitentan 10 mg, Tadalafil 20 mg, Macitentan 10 mg/Tadalafil 20mg FDC
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actelion
Schizophrenia, Schizoaffective Disorders
Bioequivalence Study Comparing 2 Formulations for 4 mg Risperidone Tablet.
The primary objective of this study is to demonstrate the bioequivalence, with respect to risperidone and its active moiety, of a single oral dose of risperidone given as a 4 mg orally-disintegrating tablet and as a 4 mg…
- Trial name
- NCT00645502
- Testing
- risperidone
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Metastatic Breast Cancer, Locally Recurrent Breast Cancer
Bioequivalence Study of IG-001 Versus Nab-paclitaxel in Metastatic or Locally Recurrent Breast Cancer
The purpose of this study is to demonstrate bioequivalence of IG-001 versus nab-paclitaxel in female patients with metastatic or locally recurrent breast cancer.
- Trial name
- TRIBECA (NCT02064829)
- Testing
- Nab-paclitaxel, IG-001
- Where
- 20 sites in United States, Georgia and 5 more
- Volunteers
- 111 people
- Sponsor
- Sorrento Therapeutics, Inc.
PAH
Bioequivalence Study of Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 Mg/40 Mg
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fed conditions.
- Trial name
- NCT06553937
- Testing
- Macitentan and Tadalafil, PrOpsynvi® Film-Coated Tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
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