Clinical trials: Fasting Period
Healthy
Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants
This is a Phase I, open-label, randomized, 2-period, 2-sequence, crossover study to demonstrate bioequivalence (BE) between the bisoprolol-amlodipine fixed-dose-combination (FDC) tablet (investigational product) and bisoprolol…
- Trial name
- NCT03226275
- Testing
- Bisoprolol-Amlodipine FDC, Bisoprolol, Amlodipine
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Anxiety Disorders
Bioequivalence Study of Paroxetine and PAXIL Under Fasting Conditions in Healthy Mexican Participants
This study will be conducted to evaluate and compare the single oral dose bioavailability of Paroxetine manufactured by GlaxoSmithKline (GSK) Pharmaceuticals S.A. for GlaxoSmithKline México, S.A. de C.V.
- Trial name
- NCT04311463
- Testing
- Paroxetine hydrochloride, PAXIL (Paroxetine hydrochloride )
- Where
- Mexico
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Levetiracetam 1000 mg Under Fasting Conditions
THe objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under…
- Trial name
- NCT00859521
- Testing
- Levetiracetam, Keppra®
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Investigate the relative bioavailability of BI 894416 as tablet formulation following a high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state (Reference, R)
- Trial name
- NCT03871595
- Testing
- BI 894416
- Where
- Germany
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study of Cephalexin Suspension in Healthy Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02123459
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Hereditary Tyrosinemia, Type I
Bioequivalence Study of Two Nitisinone Formulations Compared to Orfadin
The purpose of this study is to determine whether Nitisinone 10 mg Tablets (Test Product 1 (TP1)) and Nitisinone 10 mg Tablets High Compritol (Test Product 2 (TP2)) are bioequivalent to the reference product Orfadin 10 mg…
- Trial name
- NCT02750709
- Testing
- Nitisinone, Nitisinone 10 mg Tablet High Compritol, Orfadin
- Where
- South Africa
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 120 mg Etoricoxib Film-coated Tablets in Healthy Volunteers
The present study is a comparative bioavailability study performed to assess bioequivalence between a Test medication (Exib 120 mg etoricoxib film-coated tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa" [Ukraine])…
- Trial name
- NCT05014490
- Testing
- Exib 120 mg etoricoxib film-coated tablets, Arcoxia® 120 mg etoricoxib film-coated tablets
- Where
- Turkey (Türkiye)
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Healthy
Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions
The objective of this study was to compare the oral bioavailability of an investigational formulation of mycophenolate mofetil (MMF) 250 mg capsules to an equivalent dose of the commercially available reference product, CellCept®…
- Trial name
- NCT00911274
- Testing
- Mycophenolate Mofetil, CellCept®
- Where
- United States
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Levetiracetam 1000 mg Under Non-Fasting Conditions
The objective of this study is to compare the rate and extent of absorption of an investigational formulation of levetiracetam 1000 mg tablet to an equivalent oral dose of the commercially available reference product under fed…
- Trial name
- NCT00859430
- Testing
- Levetiracetam, Keppra®
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Determine the Bioequivalence of Two Formulations of Hyoscine Butylbromide.
Determine bioequivalence of two forumulations with hyoscine butylbromide 10mg sugar coated tablets.
- Trial name
- NCT02516098
- Testing
- hyoscine butylbromide
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteers
A Study of Cephalexin in Healthy Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02100826
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Therapeutic Equivalency
Bioequivalence of Azathioprine Suspension 10 mg/mL (Jayempi) Versus Azathioprine Tablet 50mg (Imurek®)
A single center, single dose, open-label, randomized, two period crossover study to assess the bioequivalence of an oral azathioprine suspension 10 mg/mL (Jayempi™) versus oral azathioprine tablet 50mg (Imurek®, Aspen Pharma…
- Trial name
- AZA (NCT03930264)
- Testing
- Azathioprine 50Mg Tab, Azathioprine 10mg/mL oral suspension
- Where
- 2 sites in United Kingdom
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nova Laboratories Limited
Infections, Bacterial
Bioequivalence Study Between GR37547 500 Milligrams (mg) Tablet Versus Ciprofloxacin 500 mg Tablet Reference Product in Healthy Adult Subjects
This two-period cross-over study will evaluate bioequivalence of GR37547 (ciprofloxacin 500 mg) tablet versus ciprofloxacin 500 mg reference tablet in healthy adult subjects under fasting conditions.
- Trial name
- NCT03150082
- Testing
- GR37547 tablet, Ciprofloxacin reference tablet
- Where
- South Africa
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteers
A Study of Cephalexin Liquid for Pediatrics in Healthy Adults Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02123472
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Healthy
Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet as Well as Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets Under Fasting Conditions.
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting conditions.
- Trial name
- NCT01451775
- Testing
- Empagliflozin
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Pain
Bioequivalence Study for Mejoral 500 Product
This will be a monocentric, single blinded, randomized, single-dose, two-periods, two-sequence, crossover bioequivalence study of two oral formulations in healthy participants under fasting conditions.
- Trial name
- NCT02504775
- Testing
- Mejoral® 500 Tablets, Tylenol® Caplets
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertension
Bioequivalence Study Between GSK3542503 Hydrochlorothiazide + Amiloride Hydrochloride 50 mg: 5 mg Tablets and Reference Product in Healthy Adult Participants Under Fasting Conditions
The combination of the diuretics amiloride hydrochloride (HCl) and hydrochlorothiazide (HCTZ) (GSK3542503) is indicated for the treatment of hypertension, congestive heart failure and hepatic cirrhosis with ascites and edema.
- Trial name
- NCT03031496
- Testing
- GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets), Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets)
- Where
- South Africa
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (Novelfarma, Turkey) Under Fasting Conditions
A single dose of Reference product containing 200 mg favipiravir and a single dose of Test product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at room temperature, in each period under fasting…
- Trial name
- Favipiravir (NCT04400682)
- Testing
- FAVIRA 200 MG Film Tablet, AVIGAN 200 MG Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novelfarma Ilaç San. ve Tic. Ltd. Sti.
Healthy
An Interaction Study to Assess Drug Levels in Fasting Healthy Adult Subjects
To date, no study has investigated whether there is a drug interaction between the protease inhibitor fosamprenavir and the integrase inhibitor raltegravir.
- Trial name
- NCT00802074
- Testing
- Raltegravir, Fosamprenavir, Ritonavir
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Garden State Infectious Disease Associates, PA
Prostatic Hyperplasia
SECOTEX® (Tamsulosin Hydrochloride) Bioequivalence Study Brazil - Fast Admin
It will be an open-label, randomized, laboratory-blind, crossover study with 02 treatments, 02 sequences, and 02 periods, in which the healthy male volunteers under fasting conditions receive, in each period, the test formulation…
- Trial name
- NCT01262989
- Testing
- Test formulation, Reference formulation
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline