Clinical trials: Bioequivalence of the Test Formulation
Healthy
Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available Reference Drug Product (Glucophage®, Bristol-Myers Squibb Company) in Fed, Healthy, Adult Subjects
Objective: A Randomized, Two-Way Crossover, Single-Dose, Open-Label Study to Evaluate the Bioequivalence of a Test Tablet Formulation of Metformin HCl (1000 mg), Compared to an Equivalent Dose of a Commercially Available…
- Trial name
- NCT00944346
- Testing
- Metformin HCl
- Where
- United States
- Sponsor
- Torrent Pharmaceuticals Limited
Healthy
To Assess the Bioequivalence of Two Pacritinib Drug Product Formulations and FMI Formulation Following Oral Administration in Healthy Subjects
A Phase 1, Open-Label, Single-Dose, Randomized, 2-Period Crossover Study to Assess the Bioequivalence of Two Pacritinib Drug Product Formulations (Phase 3 Clinical Trial [P3CT] Formulation [Reference] and Final Market Image [FMI]…
- Trial name
- NCT02823171
- Testing
- Treatment A: 400 mg Pacritinib P3CT, Treatment B: 400 mg of pacritinib FMI
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- CTI BioPharma
Healthy
Clarithromycin 500 mg Extended Release Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioequivalence of a test clarithromycin extended release formulation to an equivalent oral dose of the commercially available extended release clarithromycin in a test…
- Trial name
- NCT00840411
- Testing
- Clarithromycin ER 500 mg tablets, BIAXIN® XL 500 mg tablets
- Where
- United States
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.
- Trial name
- NCT00883883
- Testing
- Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria), Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy Adult Subjects
A Pharmacokinetic Study to Evaluate the Bioequivalence of a Test Formulation Compared to an Equivalent Dose of a Reference Drug Product
To assess the bioequivalence of esomeprazole of the TEST product vs. the REFERENCE product in healthy volunteers who reside in Taiwan.
- Trial name
- NCT02444507
- Testing
- Nexium powder for injection and infusion 40 mg, Esomelone Powder for Solution for Injection / Infusion 40 mg
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- isRed Pharma & Biotech Research Corporation
Healthy
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions
The purpose of this study is to compare the bioequivalence of a test formulation of zolpidem tartrate tablets to an equivalent oral dose of the commercially available reference drug product Ambien® (zolpidem tartrate tablets) in…
- Trial name
- NCT00684814
- Testing
- Zolpidem Tartrate 10 mg tablet, Zolpidem Tartrate 10 mg tablet (Ambien®)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Hypercholesterolaemia
Rosuvastatin Calcium Bioequivalence Study - Fast
This is an open-label, randomized, two treatment, two sequences, two periods crossover study, using a crossover 2x2 design, where each subject will be randomly assigned to reference or test formulation, in order to evaluate if…
- Trial name
- NCT01711749
- Testing
- Crestor®, rosuvastatin calcium tablets
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Pain
Bioequivalence of a Test Troche Formulation of Fentanyl Citrate (400 mcg) Compared to Actiq® 400 mcg, Cephalon, Inc.
The purpose of this study was to evaluate the oral bioequivalence of the Mallinckrodt test fentanyl citrate oral transmucosal 400 mcg troche compared to Actiq 400 mcg (Cephalon, Inc.) under fasting conditions.
- Trial name
- NCT01173627
- Testing
- Test fentanyl citrate 400 mcg troche, Actiq 400 mcg
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
Benazepril HCl 40 mg Tablets, Fasting
The objective of this randomized, single-dose, two-way crossover evaluation is to compare the oral bioavailability of a test benazepril HCl formulation (TEVA Pharmaceutical Industries Ltd.) to an equivalent oral dose of the…
- Trial name
- NCT00836576
- Testing
- Benazepril HCl 40 mg Tablets, Lotensin® 40 mg Tablets
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Fasting Study of Chlorpheniramine Polistirex and Hydrocodone Polistirex Capsules and Tussionex® Pennkinetic® Extended Release Oral Suspension
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt extended release test capsule formulation of chlorpheniramine polistirex/hydrocodone…
- Trial name
- NCT00853294
- Testing
- Chlorpheniramine polistirex equivalent to 8 mg of chlorpheniramine maleate and hydrocodone polistirex equivalent to 10 mg of hydrocodone bitartrate capsule, 5 mL chlorpheniramine (8 mg/5 mL)/hydrocodone (10 mg/5 mL) extended release oral suspension
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy Volunteers
A Study of the Safety, Tolerability, and Bioequivalence of Orally Administered Venglustat in Healthy Adult Participants
The purpose of this study is to assess the bioequivalent effect of venglustat in tablet and hard capsule form when give with water under fasting conditions.
- Trial name
- NCT06418607
- Testing
- Venglustat
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Sanofi
Healthy
Fed Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral…
- Trial name
- NCT00853268
- Testing
- Controlled-Release Oxycodone Hydrochloride 40 mg, OxyContin® 40 mg tablet
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fed conditions.
- Trial name
- NCT00882154
- Testing
- Cefdinir 300 mg Capsule (Sandoz, Austria), Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Bioequivalence Study of Two Extended Release Formulations Containing 50 mg of Quetiapine.
Bioequivalence study of quetiapine in healthy volunteers, comparing the test extended release formulation, Kemoter XR with respect to the reference product, Etiasel XR ® from AstraZeneca S.A., under a single-dose, two-way…
- Trial name
- NCT03317236
- Testing
- Quetiapine
- Where
- Argentina
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Laboratorio Elea Phoenix S.A.
Healthy Male Subjects
Evaluation of Dose-response, Pharmacodynamic and Pharmacokinetic Bioequivalence of Filgrastim in Healthy Male Volunteers After Single and Multiple-dose Subcutaneous Administration of the Test Injectable Formulation BK0023 vs. Neupogen®
Study rationale: Bio-ker has developed the new formulation of filgrastim BK0023 with the same active content as Neupogen®. BK0023 is expected to have the same tolerability profile and clinical effects as Neupogen® in controlling…
- Trial name
- NCT01933971
- Testing
- Filgrastim test, Filgrastim reference
- Where
- Switzerland
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Bio-ker S.r.l.
Schizophrenia
The Bioequivalence Of Two Different Lurasidone Formulations In Patients
A Phase I, Bioequivalent Study between 2 Formulations of Lurasidone HCl
- Trial name
- NCT01082250
- Testing
- Lurasidone HCl
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Sumitomo Pharma America, Inc.
Healthy Volunteers
A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants
The purpose of this study is to assess the bioequivalence of a single dose of fezolinetant test formulation compared to a single dose of fezolinetant reference formulation under fasting conditions.
- Trial name
- NCT04277624
- Testing
- fezolinetant - test formulation, fezolinetant - reference formulation
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 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 hydromorphone 8 mg to an equivalent oral dose of a commercially…
- Trial name
- NCT00853554
- Testing
- Hydromorphone Hydrochloride tablet 8 mg, Dilaudid® tablet 8 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Bioequivalence of the Test Formulation
Ibuprofen 4% (w/v) Pivotal Bioequivalence Study
Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor® Junior by determining and comparing the rate and extent of absorption in both fed and fasted states
- Trial name
- NCT03496324
- Testing
- Nurofen for Children®, Algifor® Junior
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
Healthy
Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral…
- Trial name
- NCT00853892
- Testing
- Controlled-Release Oxycodone Hydrochloride 40 mg tablet, OxyContin® 40 mg tablet
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt