Clinical trials: Bioequivalence Study
Healthy
A Study of Newly Formulated Tylenol Tablet (Acetaminophen) and 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 milligram [mg]) with respect to the Tylenol 8 hour (H) extended-release (ER) tablet (acetaminophen 650 mg) in…
- Trial name
- NCT04214691
- Testing
- Acetaminophen
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Healthy
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions
The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting conditions.
- Trial name
- NCT00778778
- Testing
- cefprozil 500mg tablets
- Where
- Canada
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Atopic Dermatitis
Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis
The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc.
- Trial name
- NCT00833079
- Testing
- Tacrolimus 0.1% manufactured by Taro, Protopic - Tacrolimus 0.1%, Tacrolimus Vehicle manufactured by Taro
- Volunteers
- 500 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Postoperative Local Analgesia
A Study on the Bioequivalence of Bupivacaine Liposome Injection in Humans
This study aims to investigate the pharmacokinetics of bupivacaine liposomal injection (test preparation) in healthy subjects. The manufactured liposomal bupivacaine injection (EXPAREL®) was used as the reference formulation to…
- Trial name
- NCT07279155
- Testing
- Bupivacaine Liposome Injection T preparation, Bupivacaine Liposome Injection R preparation
- Where
- China
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule
The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the…
- Trial name
- NCT01202435
- Testing
- Pregabalin controlled release, 82.5 mg, Pregabalin immediate release, 25 mg
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Melanoma, BRAF V600 Mutation
Bioequivalence Binimetinib 3 x 15 mg and 45 mg Formulations
The current commercially available MEKTOVI® (binimetinib) 15 mg tablets are provided as immediate release film-coated tablets for oral administration.
- Conditions
- Melanoma, BRAF V600 Mutation, Unresectable Melanoma, Metastatic Melanoma
- Trial name
- NCT05810740
- Testing
- Binimetinib 15 MG, Binimetinib 45 MG
- Where
- France
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Pierre Fabre Medicament
Healthy
Bioequivalence Study of Two Formulations of Pramipexole Tablets 0.25 mg
The present study was conducted to find out whether the bioavailability of 0.25 mg pramipexole tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals was equivalent to the reference drug (Sifrol® tablet 0.25 mg…
- Trial name
- NCT02660060
- Testing
- Pramipexole Dexa Medica, Pramipexole Boehringer Ingelheim Pharma
- Where
- Indonesia
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Invasive Candidiasis
Evaluate Bioequivalence of Micafungin (50mg/Vial)
A randomized, single-dose, two-way crossover study to evaluate bioequivalence of two formulations of micafungin (50 mg/vial) after intravenous infusion of 50 mg micafungin in healthy volunteers under fasting conditions
- Trial name
- NCT05496725
- Testing
- Micafungin
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
To Determine the Bioequivalence Study Under Fasting
Bioavailability Study of Leflunomide Tablets Under Fasting Conditions
To compare the single-dose Bioavailability of Kali and Aventis
- Trial name
- NCT00652665
- Testing
- Leflunomide, ARAVA
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy Subjects
Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233227
- Testing
- Dutasteride-Test product, Dutasteride-Reference product
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
Acne Vulgaris
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris
- Trial name
- NCT03393494
- Testing
- Adapalene and Benzoyl Peroxide Topical Gel, Epiduo Topical Product
- Where
- United States
- Volunteers
- 825 people
- Sponsor
- Padagis LLC
Advanced Tumors
A SHR-1210 BE Study on Healthy Subjects
The purpose of this study is to assess the bioequivalence of SHR-1210 before and after process changes.
- Trial name
- NCT05799183
- Testing
- SHR-1210
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Bioequivalence Study of Lu AF35700
The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg
- Trial name
- NCT03394482
- Testing
- Lu AF35700 5 mg clinical formulation, Lu AF35700 5 mg commercial formulation, Lu AF35700 10 mg clinical formulation
- Where
- United Kingdom
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy Adult Subjects
A Bioequivalence Study of Famitinib Malate on Healthy Chinese Volunteers
The primary objective is to evaluate the bioequivalence of famitinib malate capsules in new and old formulations after oral dose under fasted condition on healthy Chinese subjects.
- Trial name
- NCT04400123
- Testing
- Famitinib malate
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Myeloma Multiple
Bioequivalence Studies of Dasatinib 100 Mg
A bioequivalence study of Dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg…
- Trial name
- BE-Dasatinib (NCT05944783)
- Testing
- Dasatinib 100 MG
- Where
- Colombia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Centro de Atencion e Investigacion Medica
Bioequivalence
Bioequivalence Study of Fluvastatin Sodium Extended Release Tablets in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the test preparation (Fluvastatin sodium extended release tablet, 80 mg) manufactured by Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Trial name
- NCT06830954
- Testing
- Group A, Reference Group
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
Cancer Which Has Either Progressed or Relapsed After Standard Therapy, or for Which no Curative or Standard Therapy is Appropriate
A Phase I, Bioequivalence Study to Evaluate Two Formulations of Bendamustine (BDM) Hydrochloride (HCl) Administered to Cancer Patients
The purpose of this study is to demonstrate that a new formulation of an Bendamustine (BDM) Hydrochloride (HCl) is bioequivalent (BE) (similar) to the commercially available product in patients with cancer.
- Trial name
- NCT02162888
- Testing
- Test Product (Bendamustine)
- Where
- 10 sites in United States
- Volunteers
- 81 people
- Sponsor
- Eagle Pharmaceuticals, Inc.
Seasonal Allergic Rhinitis
A Multicenter, Randomized, Double-blind, Three-arm, Parallel Clinical Endpoint Bioequivalence Study of Monometasone Furoate Nasal Spray in Patients With Seasonal Allergic Rhinitis
Taking the mamsonic acid nasal spray held by Zhejiang Xianxian Pharmaceutical Technology Co., Ltd. as the test agent,Bannicate nose spray (product name: inside: insideSchuro®) is a reference preparation.
- Trial name
- NCT06200766
- Testing
- Mometasone furoate as a nasal spray
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Zheng Liu ENT
Healthy
Bioequivalence Study of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg Tablets Under Fed Conditions
The purpose of this study is to assess the bioequivalence of Ibuprofen 200 mg + Pseudoephedrine HCL 30 mg under fed conditions.
- Trial name
- NCT01132222
- Testing
- Ibuprofen + Pseudoephedrine Hydrochloride
- Where
- India
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Solid Tumor Cancer
Bioequivalence Study of Trifluridine and Tipiracil Hydrochloride Tablets on Fasting and Fed in Humans
The test formulation of Trifluridine and Tipiracil Tablets (20 mg) is bioequivalent to the reference formulation (Lonsurf®) in Chinese patients with solid tumors under fed and fasting conditions.
- Trial name
- NCT07492173
- Testing
- Trifluridine and Tipiracil Tablets, Lonsurf®
- Where
- China
- Volunteers
- 76 people
- Sponsor
- Shandong New Time Pharmaceutical Co., LTD