Clinical trials: Fasting Period
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
Comparison of One Morphine Sulfate Sustained-Release 200mg Capsule With Two 100 mg KADIAN Capsules Under Fasting Conditions
The objective of this single-dose, open-label, randomized, two-period crossover study was to compare the rate of absorption and oral bioavailability of a test formulation of morphine sulfate 200 mg sustained-release capsules…
- Trial name
- NCT00759759
- Testing
- morphine sulfate sustained-release capsules, KADIAN (morphine sulfate sustained-release) capsules
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Pain
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants.
- Trial name
- NCT05737069
- Testing
- Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen)
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- HALEON
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
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
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
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
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.
Acute Pain
Pharmacokinetic Study of Paracetamol UNIFLASH (125 MG/1.25 ML)
This study aims to assess the pharmacokinetic profile of a new paracetamol formulation (paracetamol Uniflash 125mg/1.25mL) for buccal use after single dose.
- Trial name
- NCT05406752
- Testing
- paracetamol Uniflash (125 mg/ 1.25 mL)
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Unither Pharmaceuticals, France
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 Volunteers
A Study of Cephalexin Capsules in Healthy Participants
The purpose of this study is to compare two different preparations of an antibiotic called cephalexin in capsules to determine if they are essentially the same. The study has two periods.
- Trial name
- NCT02123446
- Testing
- Cephalexin
- Where
- Mexico
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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
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.
Fever, Pain
Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions
This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and…
- Trial name
- NCT06855576
- Testing
- Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- HALEON
Bioequivalence
Bioequivalence Study of Two Oral Haloperidol Tablets Formulations in Healthy Subjects Under Fasting Conditions
The purpose on this study was to determine whether the test product, Haloperidol Tablets, 2 mg (Cycle Pharmaceuticals Ltd), and the reference product, Haloperidol Tablets, United States Pharmacopeia (USP), 2 mg (Mylan…
- Trial name
- NCT04411940
- Testing
- Haloperidol Tablets, Mylan Pharmaceuticals Inc., Haloperidol Tablets, Cycle Pharmaceuticals Ltd
- Where
- South Africa
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Infections, Bacterial
Bioequivalence Study Between SKF101804 Cefixime 200 Milligram (mg)/5 Milliliter (mL) Suspension Versus Cefixime 200 mg/5 mL Suspension Reference Product in Healthy Adult Subjects Under Fasting Conditions
This study is open-label, randomized two-way cross-over study to determine if cefixime 200 mg/5 mL powder for suspension (test formulation: SKF101804) is bioequivalent to cefixime 200 mg/5 mL suspension reference formulation.
- Trial name
- NCT03408392
- Testing
- Test formulation A, Reference formulation B
- Where
- South Africa
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Effect of Slow Release Hydrocortisone on Fed & Fasting Volunteers; Immediate Release on Fasting Only
The purpose of the study is to find out whether food has an effect on the way the body deals with modified release hydrocortisone, and to compare with the pharmacokinetics of immediate release hydrocortisone (fasted).
- Trial name
- NCT02408068
- Testing
- Dexamethasone, Chronocort: fasted, Immediate release hydrocortisone: fasted
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Neurocrine UK Limited
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
Ovarian Cancer, Breast Cancer
A Crossover Bioequivalence Study of Olaparib Tablets, 150 mg (Lek Pharmaceuticals d.d.) and Lynparza® (Olaparib) Tablets 150 mg (AstraZeneca Pharmaceuticals LP), in Patients With Breast Cancer Gene (BRCA) Mutated Ovarian Cancer, Recurrent Ovarian Cancer or Metastatic Breast Cancer
This is a two-way crossover bioequivalence study between test and reference product in patients diagnosed with BRCA mutated ovarian cancer, recurrent ovarian cancer or metastatic breast cancer.
- Trial name
- NCT05258747
- Testing
- Olaparib tablets, 150 mg, Lynparza® (olaparib) tablets 150 mg
- Where
- India
- Volunteers
- 70 people
- Sponsor
- Sandoz
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