Clinical trials: Bioequivalence Study in Healthy Subjects
Healthy
Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of ziprasidone 20 mg capsules versus Geodon 20 mg capsules under fasting conditions.
- Trial name
- NCT01581866
- Testing
- Ziprasidone Hydrochloride
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Heart Failure With Left Ventricular Ejection Fraction Greater Than or Equal to 40 Per Cent, Healthy Volunteers
A Study to Compare How Much of the Study Treatment Finerenone Gets Into the Blood When the Same Amount is Taken in One and in Two Tablets of Different Strengths in Healthy Male Participants
In this bioequivalence study, healthy male participants took the study treatment finerenone in the form of one and two tablets of different strengths by mouth.
- Trial name
- NCT07116512
- Testing
- Finerenone (BAY94-8862): intervention A, Finerenone (BAY94-8862): intervention B
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
The objective of this single-dose, open-label, randomized, two-treatment, two-period crossover study was to compare the relative bioavailability of a test formulation of KADIAN (2 x 10 mg) capsules manufactured by Alpharma Inc.
- Trial name
- NCT00759902
- Testing
- morphine sulfate extended-release capsules, KADIAN (morphine sulfate extended-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Healthy
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector compared to mirikizumab (reference) solution…
- Trial name
- NCT05515601
- Testing
- Mirikizumab
- Where
- 6 sites in United States
- Volunteers
- 396 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
A Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Extended Release With Respect to Metformin Extended Release Tablet Coadministered With Canagliflozin in Healthy Fed and Fasted Participants
The purpose of this study is to evaluate bioequivalence of the metformin component of the Fixed Dose Combination (FDC) tablet compared with the metformin Extended Release (XR) tablet coadministered with canagliflozin in healthy…
- Trial name
- NCT02851212
- Testing
- Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC], Canagliflozin, Metformin Extended Release (XR)
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Healthy
Food Study of Lamotrigine Tablets 25 mg to Lamictal® Tablets 25 mg
The objective of this study was to investigate the bioequivalence of Mylan's lamotrigine 25 mg tablets to GlaxoSmithKline's (GSK) Lamictal® 25 mg tablets following a single, oral 50 mg (2 x 25 mg) dose administration under fed…
- Trial name
- NCT00647751
- Testing
- Lamotrigine Tablets 25 mg, Lamictal® Tablets 25 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Bioequivalence Study in Healthy Subjects
Comparative Study of the Pharmacokinetics and Bioequivalence of Two Flupentixol Formulations
To establish bioequivalence between new film-coated tablet formulations of 0.5 mg, 1 mg and 5 mg flupentixol and the marketed coated tablet formulations of 0.5 mg, 1 mg, and 5 mg flupentixol, administered as single doses
- Trial name
- NCT02660840
- Testing
- 0.5 mg Flupentixol film-coated tablet (test treatment), 1 mg Flupentixol film-coated tablet (test treatment), 5 mg Flupentixol film-coated tablet (test treatment)
- Where
- Russia
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Healthy
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation.
- Trial name
- NCT00987779
- Testing
- Gabapentin
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Mental Disorders
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Trial name
- NCT00449774
- Testing
- Lamotrigine IR tablets, Lamotrigine ODT tablets
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
The primary objective of the study is to establish if the same amount of drug is absorbed into the blood after ingesting a combination dapagliflozin/metformin tablet vs.
- Trial name
- NCT01055691
- Testing
- Dapagliflozin/Metformin, Dapagliflozin, Metformin
- Where
- Germany
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411940
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Healthy Volunteers
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1558 in Healthy Adult Volunteers
This study aims to compare the pharmacokinetics and safety following administration of DWJ1558 and co-administration of DWC202310 and DWC202311 in healthy volunteers.
- Trial name
- NCT06010589
- Testing
- DWJ1558, DWC202310 and DWC202311
- Where
- South Korea
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
Fasting Study of Verapamil HCl Extended-Release Capsules 300 mg to Verelan® PM Extended-Release Capsules 300 mg
The objective for this study was to investigate the bioequivalence of Mylan's verapamil HCl extended-release 300 mg capsules to Schwarz's Verelan® PM extended-release 300 mg capsules following evening administration of a single…
- Trial name
- NCT00648050
- Testing
- Verapamil Hydrochloride Extended-Release Capsules, 300 mg, Verelan® PM Extended-Release Capsules, 300 mg
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Fasting
Bioequivalence Study of Lisinopril Tablets 40 mg Under Fasting Condition
This is a randomized, balanced, open Label, two-treatment, two-period, two-sequence, single dose, crossover pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01735318
- Testing
- Lisinopril Tablets 40 mg, Lisinopril
- Where
- India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Desloratadine and Pseudoephedrine Extended-release Tablets Under Fed Conditions
This is an open label, randomised, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01506791
- Testing
- Desloratadine and pseudoephedrine
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Fed
Bioequivalence Study of Olanzapine Orally Disintegrating Tablets, 5 mg Under Fed Condition
The purpose of this study is to compare the single oral dose bioequivalence of olanzapine 5 mg OD tablets with Zyprexa Zydis 5 mg tablets under fed conditions and to monitor adverse events and ensure safety of subjects.
- Trial name
- NCT01503450
- Testing
- Olanzapine OD Tablets 5 mg
- Where
- India
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Bioequivalence
Bioequivalence Study of Bosentan 125 mg Tablets Immediate Release (IR) Versus Tracleer® 125 mg Tablets IR In Healthy Subjects
Bioequivalence Study of 2 formulation of bosentan (Bosentan GEROPHARM vers. Tracleer® Actelion)
- Trial name
- NCT04101370
- Testing
- Bosentan 125 mg, Tracleer 125Mg Tablet
- Where
- Russia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
- Trial name
- NCT02307461
- Testing
- IPI-145 (duvelisib), IPI-145
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- SecuraBio
Healthy Adults
Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.
This study is an open-label, 2-way crossover, single-dose study that is being performed to establish the bioequivalence of TNX-102 SL 2.8 mg tablets from two manufacturers: manufacturer of the Phase 2/3 drug product and…
- Trial name
- NCT03168022
- Testing
- Treatment A, Treatment B
- Where
- Canada
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Healthy
Ivermectin Solution Bioequivalence Study - Fasted
The purpose of this study was to compare the pharmacokinetic and bioavailability profile (rate and amount of absorption into the bloodstream) of a test formulation of ivermectin solution 1 mg/ml with a marketed reference…
- Trial name
- NCT00921154
- Testing
- ivermectin
- Where
- Ireland
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide