Clinical trials: Fasting Period
Healthy
Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions
The study was an open label, balanced, randomized, two-treatment, four-period, two sequence, single oral dose, crossover, fully replicate bioequivalence study of two formulations of Valsartan 320 mg under fasting conditions.
- Trial name
- NCT02197442
- Testing
- Valsartan
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy
Buprenorphine 8 mg Sublingual Tablets Under Fasting Conditions
The object of this study is to compare the rate and extent of absorption of an investigational formulation of buprenorphine 8 mg sublingual tablets manufactured by Barr Laboratories, Inc.
- Trial name
- NCT01157169
- Testing
- Buprenorphine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions
An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr.
- Trial name
- NCT01045642
- Testing
- Omeprazole
- Where
- India
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's 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
Bioequivalence Study of Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg Under Fasting Conditions
This is an open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03706300
- Testing
- Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Hypertension
Bioequivalence Study of Azilsartan Medoxomil 80 mg Tablets (Gedeon Richter Plc., Hungary) and Edarbi® 80 mg Tablets (JSC Nizhpharm, Russia)
ACEis are among the most widely used classes of antihypertensive drugs. ARBs have a similar antihypertensive efficacy and protective effect as ACEis, albeit with a somewhat different mechanism for RAS inhibition and a smaller…
- Trial name
- NCT06990204
- Testing
- Azilsartan medoxomil 80 mg tablet, Edarbi® 80 mg tablets
- Where
- Russia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gedeon Richter Plc.
Pharmacokinetics
Fasted Bioequivalence Study of Clopidogrel Film-coated Tablets, 75 mg in 48 Healthy, Adult Male and Female Subjects.
This study was designed to compare bioequivalence of the Test Product Clopidogrel bisulfate, film-coated tablets, 75 mg (JSC Farmak, Ukraine) and Reference Product Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie…
- Trial name
- NCT05125549
- Testing
- Сlopidogrel bisulfate film-coated tablets, 75 mg (JSC Farmak, Ukraine), Plavix® 75 mg film-coated tablets (Sanofi Winthrop Industrie, France)
- Where
- Ukraine
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Joint Stock Company "Farmak"
Healthy
Bioequivalence Study of Tramadol Hydrochloride /Paracetamol Tablets Versus Ultracet Tablets
The sponsor, Pfizer has developed a formulation of tramadol hydrochloride/ paracetamol 37.5 mg/ 325 mg (test drug) as a generic alternative to the reference listed product Ultracet®.
- Trial name
- NCT03803371
- Testing
- Ultracet Tablets, Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)
- Where
- Brazil
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Pfizer
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.
Healthy
Bioequivalence Study of Quetiapine Fumarate Tablets 300 mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, crossover, multicentric experimental bioequivalence study.
- Trial name
- NCT01566487
- Testing
- Quetiapine fumarate
- Where
- India
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
The purpose of this study is to assess bioequivalence between a Combination caplet with loperamide hydrogen chloride (HCl) 2 milligram (mg) and simethicone 125 mg, and Imodium Express tablets-lyophilizate with loperamide HCl 2 mg…
- Trial name
- NCT04186936
- Testing
- Combination Caplet with Loperamide HCl and Simethicone, Loperamide HCl, Simethicone
- Where
- Russia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- McNeil AB
Psoriasis and Psoriatic Arthritis
Bioequivalence Study of Two Products of Apremilast 30 mg Tablets in Healthy, Adult, Human Subjects
An open label, balanced, randomized, two-sequence, two-treatment, two-period, single oral dose, crossover, bioequivalence study in normal, healthy, adult, human subjects under fasting condition
- Trial name
- NCT06084663
- Testing
- Apremilast 30 mg Tablets, Otezla 30 mg film-coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Bioequivalance, Post-menopause
An Open-label, Randomized, Single-dose, Two-treatment, Four-period, Fully Replicate Crossover Bioequivalence Study in Healthy Female Adult Participants Under Fasting Conditions Comparing the Test Product, Prontogest Solution for IM Injection With the Reference Product, Progesterone Injection
Bioequivalence study of two injectable formulation of progesterone in healthy post-menopausal women
- Trial name
- Prontogest (NCT07495007)
- Testing
- Progesterone IM of 100 mg
- Where
- Egypt
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Zi Diligence Biocenter
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
Bioequivalence
Bioequivalence Study for Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 50 mcg Inhalation Powder in Healthy Volunteers
Bioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
- Trial name
- NCT05982990
- Testing
- Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals, ADVAIR DISKUS® 250/50
- Where
- Greece
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Respirent Pharmaceuticals Co Ltd.
Healthy
A Study of the Newly Formulated Tylenol Tablet (Acetaminophen) to the Tylenol 8 Hour (H) Extended Release (ER) Tablet (Acetaminophen) in Healthy Participants
The purpose of this study is to evaluate the bioequivalence of the newly formulated Tylenol tablet (acetaminophen 650 mg) with respect to the Tylenol 8 Hour (H) Extended Release (ER) tablet (acetaminophen 650 mg) in healthy…
- Trial name
- NCT04230252
- Testing
- Acetaminophen
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Janssen Korea, Ltd., Korea
Healthy Volunteers
A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects
A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg…
- Trial name
- NCT02088918
- Testing
- Nateglinide, Nateglinide/Metformin, Metformin
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Bioequivalence
Bioequivalence Study of Bosiqing and ABILIFY Under Fasting/Fed Condition
To compare the rate and extent of absorption of Aripiprazole Orally disintegrating tablets 10 mg of Chengdu Kanghong Pharmaceutical Group Co.,Ltd, China and ABILIFY (Aripiprazole) 10 mg orodispersible tablets of Otsuka…
- Trial name
- NCT03232710
- Testing
- Bosiqing, abilify
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
Breast Cancer
Bioequivalency Study of Exemestane 25 mg Tablet Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under fasted conditions
- Trial name
- NCT01331421
- Testing
- exemestane
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
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