Clinical trials: Fasting
Healthy
Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose…
- Trial name
- NCT00649974
- Testing
- Valacyclovir Hydrochloride Tablets 1000 mg, Valtrex® Tablets 1000 mg
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Losartan 100 mg Tablets in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of losartan 100 mg tablets (test) versus Cozaar® (reference), administered as 1 * 100 mg tablet under fasting conditions.
- Trial name
- NCT01124162
- Testing
- Losartan, Cozaar®
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Pain
A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.
- Trial name
- NCT01316978
- Testing
- Ibuprofen
- Where
- Canada
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Infection
Bioequivalency Study of Clarithromycin Tablets Under Fasting Conditions
The objective of this study was the bioequivalence of a potential generic 250 mg clarithromycin tablet formulation compared with Abbott Laboratories 250 mg clarithromycin tablet, Biaxin® following a single 250 mg dose…
- Trial name
- NCT00601315
- Testing
- Clarithromycin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Healthy Volunteers
A Study to Evaluate the Safety, PK of GC2129A in Healthy Volunteers Under Fasting Conditions
The purpose of this study is to evaluate the safety and pharmacokinetics of oral administration of GC2129A in fasting conditions to healthy adult volunteers.
- Trial name
- NCT05703984
- Testing
- GC2129A(Period 1), Linaglptin 5mg and Metformin Hydrocholoride 1000mg(Period 1), GC2129A(Period 2)
- Where
- South Korea
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GC Biopharma Corp
Bioequivalence
Bioequivalence Study of Metformin 1000 mg Tablets Immediate Release (IR) Versus Glucophage® 1000 mg Tablets IR In Healthy Subjects
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Merck )
- Trial name
- NCT03458208
- Testing
- Metformin, Glucophage®
- Where
- Russia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Geropharm
Healthy
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride extended-release tablets to ALZA's Ditropan XL® tablets following an oral, single 20 mg (2 x 10 mg) dose under…
- Trial name
- NCT00649129
- Testing
- Oxybutynin Chloride ER Tablets 10 mg, Ditropan XL® Tablets 10 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
- Trial name
- NCT00834977
- Testing
- Amlodipine-benazepril 10 mg-20 mg capsules, Lotrel® 10 mg-20 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study in Healthy People to Compare 3 Different Formulations of Apremilast Tablets Taken With or Without Food
The aim of this trial is to establish bioequivalence between EU-, US- and Japan-sourced Otezla® tablet formulations to assure comparability of results from Phase III trials of BI 730357 (new oral agent for treatment of psoriasis…
- Trial name
- NCT04811573
- Testing
- EU-sourced Otezla®, US-sourced Otezla®, Japan-sourced Otezla®
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes
Study to Compare the Bioavailability of Extended Release Metformin HCl Tablet Versus Glucophage XR® Tablets in Healthy Human Volunteers Under Fasting Condition
Objective: To compare the bioavailability of Extended Release Metformin HCl Tablet(Test formulation, Torrent Pharmaceuticals Ltd.,India) versus Glucophage XR® Tablets ( Reference formulation, Bristol-Myers Squibb Company, USA) in…
- Trial name
- NCT01089166
- Testing
- Metformin
- Where
- India
- Sponsor
- Torrent Pharmaceuticals Limited
Pulmonary Arterial Hypertension
Effect of BIA 5-1058 400 mg on Warfarin Pharmacokinetics
The purpose of this study is: To investigate CYP2C9 inhibition by BIA 5-1058 through the assessment of its effect on the Pharmacokinetic (PK) of S-warfarin, a substrate of CYP2C9.
- Trial name
- NCT04994119
- Testing
- BIA 5-1058, Warfarin
- Where
- Germany
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Pre-diabetes
A Study to Evaluate the Effects of Vildagliptin on the Insulin Response to Glucose in Subjects With Pre-diabetes
This is an exploratory study to assess whether vildagliptin, an unapproved drug, can increase insulin secretion in subjects with pre-diabetes who have a defect in the insulin response and elevated levels of fasting glucose.
- Trial name
- NCT00312130
- Testing
- Vildagliptin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Novartis
Diabetic Peripheral Neuropathy, Fibromyalgia
Pharmacokinetics of Two Formulation of Pregabalin
A Randomized, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of Two Formulations of Pregabalin after Oral Administration in Healthy Volunteers under Fasting Conditions
- Conditions
- Diabetic Peripheral Neuropathy, Fibromyalgia, Partial Seizure Disorder
- Trial name
- NCT03712475
- Testing
- Pregabalin
- Where
- Taiwan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Other
A Study of IW-6463 in Healthy Volunteers
Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of…
- Trial name
- NCT03856827
- Testing
- IW-6463
- Where
- Netherlands
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Tisento Therapeutics
Congestive Heart Failure, Chronic Kidney Diseases
Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects
The study will evaluate the within-subject variability of 20mg ER torsemide as compared to 20mg IR torsemide (Demadex) in fully replicate double-crossover trial in healthy volunteers, who are consuming a high-salt diet (300…
- Trial name
- NCT03214874
- Testing
- Demadex 20mg Tablet, ER Torsemide 20mg Tablet
- Where
- India
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sarfez Pharmaceuticals, Inc.
Healthy
Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions
Objective: To compare the rate and extent of absorption of Torrent Pharmaceuticals Limited, India, sertraline and Pfizer, Inc., USA (Zoloft) sertraline, administered as a 1X100 mg tablet, under fasted conditions.
- Trial name
- NCT00944242
- Testing
- Sertraline, Sertraline Hydrochloride
- Where
- Canada
- Sponsor
- Torrent Pharmaceuticals Limited
Liver Failure
Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test
The purpose of this study is to investigate safety and efficacy of intravenously injected 0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on patients with partial liver resection.
- Trial name
- NCT01785082
- Testing
- 13-C-Methacetin
- Where
- 4 sites in Germany
- Volunteers
- 149 people
- Sponsor
- Humedics GmbH
Nasal Congestion
Bioequivalence of Single Dose Phenylephrine Extended Release Tablets and Phenylephrine HCl Immediate Release Tablets Dosed Every Four Hours (P08340)(COMPLETED)
This study will assess the food-effect bioavailability of an extended release formulation of phenylephrine HCl and its bioequivalence to the marketed immediate release phenylephrine HCl product.
- Trial name
- NCT01354418
- Testing
- Phenylephrine HCl Extended Release, Phenylephrine HCl Immediate Release
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Bayer
Healthy
15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting
This study will compare the relative bioavailability (rate and extent of absorption) of 15 mg Mirtazapine (Orally Disintegrating) Tablets manufactured by TEVA Pharmaceutical Industries, Ltd.; distributed by TEVA Pharmaceuticals…
- Trial name
- NCT00834197
- Testing
- Mirtazapine 15 mg (Orally Disintegrating) Tablets, REMERON SolTab® 15 mg Orally Disintegrating Tablets
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets Under Fasting Conditions
To Demonstrate the Relative Bioavailability of Bupropion HCI 100 mg Tablets under Fasting Conditions.
- Trial name
- NCT00883155
- Testing
- Bupropion HCl 100 mg Tablets (Invamed Inc.), Wellbutrin 100 mg Tablets (Glaxo Wellcome)
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sandoz