Clinical trials: Fasting Conditions
Hypertension
Bioavailability Study of Candesartan Cilexetil 8mg Tablet Under Fasting Conditions
This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference…
- Trial name
- NCT02006589
- Testing
- Candesartan cilexetil (GW615775, Test formulation), Candesartan cilexetil (Reference treatment)
- Where
- India
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Venlafaxine 25 mg Tablets Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of venlafaxine 25 mg tablets (test) versus Effexor® (reference) administered as 1 x 25 mg tablet under fasting conditions.
- Trial name
- NCT00834964
- Testing
- Venlafaxine 25 mg Tablets, Effexor® 25 mg Tablets
- Where
- 2 sites in Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Sudden Cardiac Death
Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications
The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.
- Trial name
- Prediction (NCT00560768)
- Testing
- Ovatio VR 6250 or DR6550
- Where
- 30 sites in United States, Canada and 2 more
- Volunteers
- 198 people
- Sponsor
- LivaNova
Healthy
Bioequivalence Study of Doxycycline Monohydrate 100mg Tablets Under Fasting Conditions
The purpose of this study was to determine the bioequivalence of Doxycycline monohydrate formulations after administration of single doses to normal healthy subjects under fasted conditions.
- Trial name
- NCT00775177
- Testing
- Doxycycline monohydrate 100mg tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Fasting
Bioequivalence Study of Lisinopril and Hydrochlorothiazide Tablets (20+25) mg Under Fasting Conditions
This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01831700
- Testing
- Lisinopril and Hydrochlorothiazide Tablets (20+25) mg, Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Fasting
Bioequivalence Study of Mycophenolate Mofetil 500 mg Tablets of Dr.Reddy's Laboratories Limited Under Fasting Conditions
To compare the bioavailability and characterise the pharmacokinetic profile of the sponsor's test formulation with respect to the reference formulation Cellcept® 500 mg tablets, in healthy, adult, human male subjects under…
- Trial name
- NCT01283841
- Testing
- Mycophenolate Mofetil
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Non-Fasting Conditions
The objective of this study is to compare the relative bioavailability of Losartan potassium/Hydrochlorothiazide 100/25 mg tablets (manufactured by Teva Pharmaceutical Industries, Ltd.
- Trial name
- NCT01149473
- Testing
- Losartan potassium/Hydrochlorothiazide
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Relapsing Remitting Multiple Sclerosis
Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects
The primary objective of this study was to assess the bioequivalence of the test product (Bafiertam; BLS-11; monomethyl fumarate) 190 mg versus Tecfidera® (dimethyl fumarate) 240 mg based on the Cmax and Area Under the Curve…
- Trial name
- NCT04570670
- Testing
- monomethyl fumarate 190 mg, dimethyl fumarate 240 mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Banner Life Sciences LLC
Pain
Conversion From Fast Acting Oral Opioids to Abstral®
The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer…
- Trial name
- NCT01315886
- Testing
- SL fentanyl
- Where
- Sweden
- Volunteers
- 8 people
- Sponsor
- Orexo AB
Therapeutic Equivalency, Healthy
Fasted Bioavailability Study of Cilostazol Tablets, 50mg
The purpose of this study is to evaluate and compare the relative bioavailability of a test formulation of cilostazol tablets to an equivalent dose of Pletal® (cilostazol) tablets after a single oral dose administered under…
- Trial name
- NCT00685802
- Testing
- Cilostazol 50 mg Tablets, Cilostazol (Pletal®) 50 mg Tablets
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 300 mg capsule fasting conditions.
- Trial name
- NCT00882700
- Testing
- Cefdinir 300 mg Capsule (Sandoz, Austria), Omnicef Cefdinir 300 mg Capsule (Abbott Laboratories, USA)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Sandoz
Bioequivalence
Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Zestril®, 20 mg) or the test (Lisinopril, 20…
- Trial name
- NCT05061901
- Testing
- Lisinopril tablet 20 mg, Zestril® tablet 20 mg
- Where
- Russia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Fasting
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 50 mg
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01884857
- Testing
- Metoprolol Succinate ER Tablets 50 mg, 'TOPROL-XL®' ER Tablets 50 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Famciclovir 500 mg Tablets Under Non-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 non-fasting conditions.
- Trial name
- NCT00834444
- 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
Healthy Adult
Bioequivalence Study of Ferric Carboxymaltose Injection in Healthy Chinese Participants
The goal of this clinical trial is to compare the pharmacokinetic profile of the developed drug product and reference product in healthy participants under fasting condition.
- Trial name
- NCT06895993
- Testing
- Ferric Carboxymaltose Injection, Ferric Carboxymaltose Injection [Injectafer®]
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Sichuan Huiyu Pharmaceutical Co., Ltd
Healthy
Cefdinir for Oral Suspension 250 mg/5mL, Non-fasting
The objective of this study is to compare the relative bioavailability of cefdinir for oral suspension 250 mg/5mL (manufactured and distributed by TEVA Pharmaceuticals USA) with that of OMNICEF® for oral suspension, 250 mg/5mL…
- Trial name
- NCT00835549
- Testing
- Cefdinir for oral suspension 250 mg/5mL, OMNICEF® for oral suspension 250 mg/5mL
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pharmacokinetics
Administration of Tramadol and Ketorolac Separately and Simultaneously to Assess a Potential Pharmacokinetic Interaction
Tramadol (Tradol) and ketorolac (Dolac) are marketed products to treat acute pain. This study was performed to determine if both medications can be given to a patient simultaneously without a change of the products'…
- Trial name
- NCT03767036
- Testing
- Tramadol hydrochloride 25 mg capsule, Ketorolac Tromethamine 10 mg tablet
- Where
- Mexico
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Grünenthal GmbH
Glimepiride BE Study in Healthy Volunteers Under Fasting Condition
Bioequivalence Study of 4 mg Glimepiride Tablet
This was a randomized, single blind, two-period, two sequence cross-over study under fasting condition to compare the bioavailability of two glimepiride 4 mg tablet formulations (test and reference formulations).
- Trial name
- NCT01677247
- Testing
- Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica, Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Healthy
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition
This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence study.
- Trial name
- NCT01506050
- Testing
- Desloratadine
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
Glimepiride 4 mg Tablets Under Fasting Conditions
The objective of this study is to compare the relative bioavailability of glimepiride 4 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd.
- Trial name
- NCT00834340
- Testing
- Glimepiride 4 mg Tablets, AMARYL® 4 mg Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
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