Clinical trials: Therapeutic Equivalency
Fasting State
Bioequivalence Study of Allopurinol 300 mg Tablets USP Under Fasting Condition
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over comparative pivotal study.
- Trial name
- NCT01603134
- Testing
- Allopurinol
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Type 2 Diabetes Mellitus
To Compare the Similarity of a Combination Dapagliflozin/Metformin Tablet With the Two Drugs Administered Separately
This is an open-label, randomised study to compare the similarity of a combination Dapagliflozin/Metformin tablet with the two drugs administered separately under fasting and fed conditions in healthy volunteers.
- Trial name
- NCT01535677
- Testing
- Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted, Dapagliflozin + Glucophage tablet fed
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
To Determine Bioequivalence Under Fed Conditions
The Study Intends to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Evaluated.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 1000/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05329857
- Testing
- Metformin and Vildagliptin 1000/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Healthy Participants
A Study to Evaluate the Bioequivalence of Ruxolitinib Extended Release (XR) Tablets With Ruxolitinib Immediate Release (IR) Tablets Administered Orally in Healthy Participants
This study is conducted to determine the Bioequivalence of Ruxolitinib XR 55 mg Tablets With Ruxolitinib IR Tablets Administered Orally in Healthy Participants
- Trial name
- NCT06555081
- Testing
- Ruxolitinib IR, Ruxolitinib XR
- Where
- United States
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Healthy
Comparative Bioavailability Study of Lisinopril Tablets, 10 mg
The purpose of this study is to compare the bioavailability of Par Lisinopril 10 mg Tablets and IPR Pharmaceuticals, Inc. Zestril (R).
- Trial name
- NCT01375244
- Testing
- Lisinopril, Zestril
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Fed Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853736
- Testing
- Roxicodone™ tablet 30 mg, Oxycodone hydrochloride tablet 30 mg
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
Fasting Study of Letrozole Tablets 2.5 mg and Femara® Tablets 2.5 mg
The objective of this study was to investigate the bioequivalence of Mylan's letrozole 2.5 mg tablets to Novartis' Femara® 2.5 mg tablets following a single, oral 2.5 mg (1 x 2.5 mg) dose administered under fasting conditions.
- Trial name
- NCT00648063
- Testing
- Letrozole Tablets 2.5 mg, Femara® Tablets 2.5 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Schizophrenia
A Bioequivalence Study of PP3M in Patients With Schizophrenia
To evaluate the bioequivalence of the test formulation paliperidone palmitate injection (3M) produced by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Trial name
- NCT07493551
- Testing
- Paliperidone Palmitate Injection (3M)
- Where
- China
- Volunteers
- 260 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Type 2 Diabetes
A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Concomitant Administration of Sitagliptin and Metformin as Individual Tablets (0431A-048)
A two-part study to demonstrate the bioequivalence of a single dose of the Final Market Image (FMI) of sitagliptin /metformin (50/500 and 50/1000 mg) Fixed-Dose Combination (FDC) tablet and co-administration of a single dose of…
- Trial name
- NCT00961857
- Testing
- sitagliptin phosphate (+) metformin hydrochloride, Comparator: metformin 500 mg, Comparator: sitagliptin
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Hypertension
A Bioequivalence Study Between Telmione 80 mg and Micardis 80 mg in Healthy Adult Volunteers
To compare the pharmacokinetics and safety after a single dose administration of Telmione® 80 mg and Micardis® 80 mg in healthy adult volunteers
- Trial name
- NCT05223101
- Testing
- Telminone 80 mg, Drug: Micardis 80 mg
- Where
- South Korea
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Healthy
Pravastatin 80 mg Tablets Dosed in Healthy Subjects Under Non-Fasting Conditions
This study compared the relative bioavailability (rate and extent of absorption) of Pravastatin Sodium Tablets 80 mg by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT00829309
- Testing
- Pravastatin
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fed Conditions
An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc.
- Trial name
- NCT00776022
- Testing
- Cetirizine Hydrochloride 10 mg tablet
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Anxiety Disorders
Bioequivalence Trial of Alprazolam 0.25 mg Tablets
The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent. Test product was Zamoprax® 0.25 mg (GlaxoSmithKline) and reference product Tafil® 0.25 mg (Pharmacia \& Upjohn).
- Trial name
- NCT01853956
- Testing
- Alprazolam 0.25 mg
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Paclitaxel Protein-bound Particles for Injectable Suspension (Albumin-bound) in Breast Cancer Patients
The main purpose of this study is to evaluate the bioequivalence of paclitaxel protein-bound particles for injectable suspension (albumin-bound) (100 mg, test product) and Abraxane® (100 mg, reference product) in breast cancer…
- Trial name
- NCT07096869
- Testing
- Paclitaxel protein-bound particles for injectable suspension (albumin-bound), Abraxane®
- Where
- China
- Volunteers
- 28 people
- Sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Healthy
Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg
The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5…
- Trial name
- NCT00648505
- Testing
- Glipizide and Metformin HCl Tablets 5 mg/500 mg, Metaglip® Tablets 5 mg/500 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Hypogonadism
A Bioequivalence Study of Testosterone Cypionate in Hypogonadal Males
This is an open-label, 2-treatment, 2-period, single dose (200 mg, IM) cross-over study, 2-part design to evaluate the bioequivalence (BE) of a reformulated presentation (test) of testosterone cypionate solution for injection…
- Trial name
- NCT03792477
- Testing
- Test formulation, Reference formulation
- Where
- 2 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study of MK-7240 in Healthy Participants (MK-7240-009)
The goal of this study is to learn what happens to MK-7240 in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of MK-7240 and if people tolerate it.
- Trial name
- NCT07405177
- Testing
- Tulisokibart Form 1, Tulisokibart Form 2
- Where
- 2 sites in Australia
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants
The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.
- Trial name
- NCT05658146
- Testing
- Mavacamten Capsule 1, Mavacamten Capsule 2, Mavacamten Capsule 3
- Where
- 3 sites in United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Bioequivalence Study of Sumatriptan Succinate Tablets 100 mg in Fed Conditions
The objective of this study was to compare the relative bioavailability of Sumatriptan Succinate Tablets 100 mg with Imitrex Tablets 100 mg under fed conditions in healthy adult human subjects.
- Trial name
- NCT01269281
- Testing
- Sumatriptan
- Where
- India
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Single Dose Two-Way Crossover Fasted Bioequivalence Study of Nabumetone 750 mg Tablets in Healthy Volunteers
The purpose of this study is to evaluate the relative bioavailability of nabumetone from 2 tablet products and determine if the 2 products were bioequivalent to each other.
- Trial name
- NCT00864968
- Testing
- Nabumetone 750 mg tablets, single dose
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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