Clinical trials: Therapeutic Equivalency
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
Generic Drug Quality, Generic Formulation Interchangeability
Generic Formulations of Commonly-used Oral Drugs in Saudi Arabia:Interchangeability & Post-marketing Quality
Generic formulations of prescription drugs can, through their relatively lower cost, improve healthcare as long as they maintain their registration-quality and public trust.
- Trial name
- NCT01344070
- Testing
- one of the 15 drugs listed below
- Where
- Saudi Arabia
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- King Faisal Specialist Hospital & Research Center
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.
Healthy
Bioequivalence Study of Risperidone 1 mg Orally-disintegrating Tablets Under Fed Conditions
The purpose of this study is to determine the pharmacokinetics and bioequivalence of Risperidone formulations after administration of single doses to normal, healthy subjects under fed conditions.
- Trial name
- NCT01222923
- Testing
- Risperidone
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
A Study to Compare Two Formulations of LY3209590 in Healthy Participants
The main purpose of this study is to compare the two formulations of LY3209590 in healthy participants. Study participants will be administered each formulation at separate study visits.
- Trial name
- NCT05914688
- Testing
- LY3209590 (Formulation 1), LY3209590 (Formulation 2)
- Where
- Singapore
- Volunteers
- 67 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Bioequivalence Study of Fenofibrate Capsules, 130 mg Under Fasting Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, crossover bioequivalence study comparing a single oral dose of fenofibrate capsules, USP 130 mg, of Ohm Laboratories Inc.
- Trial name
- NCT02306889
- Testing
- Fenofibrate, ANTARA® (fenofibrate)
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fasting
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.
- Trial name
- NCT01831674
- Testing
- Metformin Hydrochloride Extended-Release Tablets USP 750, GLUCOPHAGE®XR tablet 750 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.
- Trial name
- NCT06393127
- Testing
- Nerandomilast
- Where
- Germany
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bilateral Cataract
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye.
- Trial name
- TBO (NCT02734459)
- Testing
- cataract surgery
- Volunteers
- 756 people
- Sponsor
- Semler Research Center Pvt. Ltd.
Healthy Volunteers
Bioequivalence Study of Rotigotine Transdermal Patch With Two Different Formulations in Healthy Japanese Subjects
To investigate and compare the drug amount delivered to the body after each single administration of Rotigotine patch with 2 different formulations in healthy Japanese subjects.
- Trial name
- NCT01565018
- Testing
- Rotigotine PR 2.1.4, Rotigotine PR 2.2.1
- Where
- Germany
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Primary Ovarian Insufficiency, Vaginitis
A Study To Compare The Amount Of Premarin Components That Is Absorbed Into The Blood Of Japanese Healthy Postmenopausal Women Following Oral Administration Of Two Different Tablets Of Premarin Under Fast and Fed Conditions.
The purpose of this study is to assess the bioequivalence and food effect for a new Premarin formulation compared with a Premarin reference tablet in Japanese healthy postmenopausal women.
- Conditions
- Primary Ovarian Insufficiency, Vaginitis, Metrorrhagia, Menopause
- Trial name
- NCT01436513
- Testing
- Premarin reference tablet (fasted), Premarin new tablet (fasted), Premarin reference tablet (fed)
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pfizer
Bioequivalence
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy…
- Trial name
- NCT03146988
- Testing
- RGB-02 or Neulasta® (pegfilgrastim)
- Where
- United Kingdom
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Healthy
Alprazolam Extended-Release 3mg Tablets Bioequivalence Study Under Fasting Conditions
This study will compare the relative bioavailability (rate and extent of absorption) of 3 mg Alprazolam Extended Release Tablets manufactured and distributed by TEVA Pharmaceuticals USA with that of 3 mg XANAX XR® Tablets by…
- Trial name
- NCT00829426
- Testing
- Alprazolam Extended-Release 3 mg Tablets
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
The objective of this study was to compare the relative bioavailability of Lansoprazole DR Capsules 30 mg with Prevacid® Capsules 30 mg under fasting conditions in healthy adult human subjects.
- Trial name
- NCT01270308
- Testing
- Lansoprazole
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Anti-Infective Agents
Cross Over Study to Prove Bioequivalence Between Two Brands of Cefalexin Suspension
A single dose, two treatments (two cephalexin suspension brands), two sequences, cross-over design was used with a washout of 7 days between the two study periods.
- Trial name
- NCT01105208
- Testing
- Cephalexin suspension (Optocef, BAYO5448 ), Cephalexin suspension (Keflex)
- Where
- Mexico
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
A Relative Bioavailability Study of Citalopram 40 mg Tablets Under Fasting Conditions
The purpose of this study is to evaluate and compare the relative bioavailability, and therefore the bioequivalence of two formulations of Citalopram after a single dose administration under fasting conditions.
- Trial name
- NCT00865085
- Testing
- Citalopram HBr 40 mg tablets, single dose, CelexaTM 40 mg tablets, single dose
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
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