Clinical trials: Comparative Bioavailability
Neuroblastoma
Oral Liquid 13-cis-retinoic Acid (13-CRA)
An open label, randomised, multiple dose, cross-over relative bioavailability and pharmacokinetics trial of a novel oral liquid and capsule formulations of 13-CRA administered to patients from 0 months - < 21 years.
- Trial name
- My-CRA (NCT03291080)
- Testing
- Liquid 13-Cis Retinoic Acid, Extracted capsules 13-CRA
- Where
- 10 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Nova Laboratories Limited
Healthy Adult Subjects
Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
To investigate the comparative bioavailability of edaravone oral suspension administered orally and via a nasogastric tube in healthy adult subjects
- Trial name
- NCT04776135
- Testing
- MT-1186
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Shionogi
Parkinson
Comparative Bioavailability Study of BIA 9-1067 25 mg Capsules
The objectives of this study were to characterize the effects of food on the pharmacokinetics (PK) and tolerability of BIA 9-1067 in healthy male subjects.
- Trial name
- NCT02071823
- Testing
- BIA 9-1067
- Where
- Canada
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Famciclovir 500 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of famciclovir 500 mg tablets (Novopharm Limited) with that of FAMVIR® 500 mg tablets (Novartis) in healthy adult subjects under fasting conditions.
- Trial name
- NCT00834431
- Testing
- Famciclovir 500 mg Tablets, Famvir® 500 mg Tablets
- Where
- 2 sites in United States, Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Acute Pain
Comparative Bioavailability of Dexketoprofen Trometamol Oral Solution vs Tablet Formulations
The purpose of this study is to compare the bioavailability of 25 mg DKP.TRIS given as an Enantyum® oral solution (Test formulation) and Keral® tablet (Reference formulation).
- Trial name
- NCT02209454
- Testing
- Enantyum® oral solution, Keral® tablet
- Where
- United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Menarini Group
Healthy
Granisetron 1 mg Tablets Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between granisetron hydrochloride 1 mg tablets (Teva Pharmaceuticals USA) and Kytril® 1 mg tablets (Roche, USA), after a single-dose in health subjects…
- Trial name
- NCT00834717
- Testing
- Granisetron hydrochloride 1 mg tablets, Kytril® 1 mg tablets
- Where
- Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Postoperative Pain
Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
- Trial name
- TKA (NCT00485693)
- Testing
- Bupivacaine HCl, SKY0402
- Where
- 9 sites in United States, Czechia
- Volunteers
- 138 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Healthy
Fed Bioavailability Study of Lovastatin Tablets and Mevacor Tablets
The purpose of this study is to evaluate and compare the relative bioavailability and therefore the bioequivalence of a test formulation of Lovastatin tablets to an equivalent dose of Mevacor® tablets after a single oral dose…
- Trial name
- NCT00684723
- Testing
- Lovastatin 40 mg Tablets, Lovastatin (Mevacor®) 40 mg Tablets
- Where
- Canada
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study
This study is being conducted to investigate the rate and extent of naproxen absorption from the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference product currently marketed in The…
- Trial name
- NCT03167541
- Testing
- Test, Reference
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
Hypertension
Telmisartan and Amlodipine Versus Monocomponent Tablets
This study will be an open-label, randomized, two-treatment, two-period, two-sequence crossover study to evaluate the bioequivalence of the amlodipine component of Boehringer Ingelheim Pharma GmbH \& Co.
- Trial name
- NCT01278797
- Testing
- Telmisartan/Amlodipine Combination Tablet, Amlodipine Monocomponent
- Where
- Canada
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Epilepsy
Single Dose Crossover Comparative Bioavailability Study of Eslicarbazepine Acetate Versus To-be-marketed Formulation
Single center, randomized, single dose, laboratory-blinded, 2-period, 2-sequence, crossover design
- Trial name
- NCT02283840
- Testing
- BIA 2-093
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Healthy
Trandolapril 4 mg Tablet Under Non-Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between trandolapril 4 mg tablets (test) and Mavik® 4 mg Tablets (reference) after a single-dose in healthy subjects under fed conditions.
- Trial name
- NCT00840073
- Testing
- Trandolapril 4 mg Tablets, Mavik® 4 mg Tablets
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Parkinson Disease
A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes
A study that compares the extent to which apomorphine becomes available in the body after taking either an investigational drug containing apomorphine or apomorphine that is injected under the skin in people with PD complicated…
- Trial name
- NCT03292016
- Testing
- APL-130277, APO-go, Apokyn
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Sumitomo Pharma America, Inc.
Healthy Participants
Riluzole Orodispersible Film Replicate Bioavailability
The objective of the study is to compare the pharmacokinetic profile of riluzole after replicate single dose of the novel orodispersible film test formulation and of the marketed reference Rilutek® tablets and to evaluate their…
- Trial name
- NCT04819438
- Testing
- Riluzole 50 mg orodispersible film, Rilutek® 50 mg riluzole tablets
- Where
- Switzerland
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Cross Research S.A.
Healthy
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fed Conditions
The objective of this study is to evaluate the comparative bioavailability between tamsulosin hydrochloride 0.4 mg capsules (Manufactured by Teva Pharmaceutical Industries Ltd.; distributed by Teva Pharmaceuticals USA) and…
- Trial name
- NCT01149733
- Testing
- Tamsulosin
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers
The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
- Trial name
- NCT02442310
- Testing
- Deferiprone delayed release tablet formulation, Deferiprone oral solution
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ApoPharma
Women at Risk for Pregnancy
A PK Study Comparing VeraCept vs. ParaGard Intrauterine Devices (IUDs)
to Assess the Pharmacokinetic Properties of VeraCept® Intrauterine Contraceptive vs ParaGard® in Healthy, Post- Menarcheal Women
- Trial name
- IUD (NCT03785366)
- Testing
- VeraCept, ParaGard
- Where
- 2 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Sebela Women's Health Inc.
Healthy
Pravastatin Sodium 80 mg Tablets Under Fasting Conditions
The objective of this study is to evaluate the comparative bioavailability between pravastatin sodium 80 mg tablets (Distributed by Teva Pharmaceuticals, USA) and Pravachol® 80 mg tablets (Bristol Myers Squibb, USA), after a…
- Trial name
- NCT00830258
- Testing
- Pravastatin sodium 80 mg tablets, Pravachol® 80 mg tablets
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Stable Renal Transplant Recipients
Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®.
- Trial name
- NCT00991510
- Testing
- mycophenolate mofetil (Myfenax), mycophenolate mofetil (Cellcept)
- Volunteers
- 43 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Epilepsy
Comparative Bioavailability Study of Two Different Sources of Eslicarbazepine Acetate
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE)…
- Trial name
- NCT02284880
- Testing
- BIA 2-093
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.