Clinical trials: Fasting Conditions
Menorrhagia
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy…
- Trial name
- PREA (NCT01190150)
- Testing
- tranexamic acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring Pharmaceuticals
Healthy Subjects
Esomeprazole Magnesium Dihydrate 40 mg Tablets Relative to Nexium 40 mg Tablets Under Fasting Condition
The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose.
- Trial name
- NCT06233097
- Testing
- Esomeprazole magnesium dihydrate-Test product, Esomeprazole magnesium dihydrate-Reference product
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bio-innova Co., Ltd
PAH
Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil Film-coated Tablets 10 mg/40 mg
Single dose oral bioequivalence study of Macitentan and Tadalafil film-coated tablets 10 mg/40 mg and 'PrOpsynvi®' Macitentan and Tadalafil film-coated tablets 10 mg/40 mg in healthy adult male subjects under fasting conditions.
- Trial name
- NCT06553924
- Testing
- Macitentan and Tadalafil film-coated tablets, PrOpsynvi® macitentan and tadalafil film-coated tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose
Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet
This was a single centre, single-blind, randomized, balanced, combined single dose study under fasting condition and multiple doses study under fed condition with normal diabetic-meal, two-period, two-sequence cross-over study to…
- Trial name
- NCT01677260
- Testing
- 500 mg metformin hydrochloride extended release caplet (test drug), 500 mg metformin hydrochloride prolonged release tablet (reference drug)
- Where
- Indonesia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Pain
Relative Bioavailability and Food Effect Study
Initial studies have used a powder in capsule formulation of PH797804. In future studies an immediate release tablet will be used.
- Trial name
- NCT00827515
- Testing
- PH797804
- Volunteers
- healthy volunteers welcome
- Sponsor
- Pfizer
Bioavailability Study
Relative Bioavailability of Early Phase and Late Phase Hetrombopag Olamine Formulations
The primary objective of the study is to evaluate the relative bioavailability of early phase and late phase hetrombopag olamine formulations in healthy Chinese adult subjects under fasting conditions.
- Trial name
- NCT04688008
- Testing
- Hetrombopag
- Where
- China
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Bioequivalence Study of Rivaroxaban 10 mg Film-coated Tablets
This study was an open-label, randomized, single-dose, two-period, two-sequence, two-way crossover study under fasting conditions which included 28 healthy adult male and female subjects.
- Trial name
- NCT06558058
- Testing
- Rivaroxaban 10 mg film-coated tablet, Xarelto 10 mg film-coated tablet
- Where
- Indonesia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Oxygen Saturation Measurement
Philips FAST Evaluation
Evaluation of Philips FAST technology with Nellcor sensors
- Trial name
- NELFST (NCT06860230)
- Testing
- Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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.
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
A Relative Bioavailability Study of 60 mg Nifedipine ER Tablets Under Non-fasting Conditions
The purpose of this study is compare the relative bioavailability of Nifedipine ER tablets 60 mg by Abrica Pharmaceuticals LLLP with that of ADALAT® CC Extended Release Tablets 60 mg by Bayer Pharmaceuticals Corporation, Bayer…
- Trial name
- NCT00864617
- Testing
- Nifedipine Extended Release tablets 60 mg, single dose, ADALAT® CC Extended Release Tablets 60 mg
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Actavis Inc.
Obesity
Rimonabant in Abdominally Obese Patients With Impaired Fasting Blood Glucose
Primary objective: To determine the effect of Rimonabant 20mg on the co-primary endpoint including Fasting Plasma Glucose (FPG), HDL-Cholesterol (HDL-C) and triglyceride (TG) levels over a period of 12 months when prescribed with…
- Trial name
- PRADO (NCT00405808)
- Testing
- Rimonabant
- Where
- 27 sites in Austria, Belgium and 25 more
- Volunteers
- 2,666 people
- Sponsor
- Sanofi
Antithrombic Drug
Bioequivalence Study of Two Products of Apixaban 5mg Tablets in Healthy, Adult, Human Subjects
To compare the bioavailability and characterize the pharmacokinetic profile of the sponsor's test product relative to that of reference product after single oral dose administration in normal, healthy, adult, human subjects under…
- Trial name
- NCT06043297
- Testing
- Apixaban 5MG, Eliquis 5 mg
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
To Determine Bioequivalence Under Fasting Conditions
Bioavailability Study of (Buspar) Buspirone HCl Tablets Under Fasting Conditions
To compare the single-dose bioavailability of Par and Bristol-Myers Squibb Buspirone HCl Tablets
- Trial name
- NCT00653419
- Testing
- buspirone HCl, Buspar
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Par Pharmaceutical, Inc.
Healthy
Bioequivalence Study of Montelukast Sodium Oral Granules 4mg Under Fasting Condition
This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study.
- Trial name
- NCT01691456
- Testing
- Montelukast sodium
- Where
- India
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy
10 mg Donepezil Hydrochloride Orally Disintegrating Tablets Under Fasting Conditions.
This study investigated the relative bioavailability (rate and extent of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating…
- Trial name
- NCT01260922
- Testing
- Donepezil Hydrochloride, Aricept®
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions
This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting conditions.
- Trial name
- NCT03696329
- Testing
- Tetrabenazine Tablets 25 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Prevention of Stroke or Systemic Embolism, Deep Vein Thrombosis (DVT)
To Compare and Evaluate the Oral Bioavailability of Edoxaban 60 mg Film Coated Tablet With That of Lixiana® 60 mg Filmtabletten (Film Coated Tablet) (Edoxaban) in Healthy, Adult, Human Subjects Under Fasting Conditions
To compare and evaluate the oral bioavailability of Edoxaban 60 mg Film Coated Tablet with that of Lixiana® 60 mg filmtabletten (Film Coated Tablet (Edoxaban) in healthy, adult, human subjects under fasting conditions.
- Conditions
- Prevention of Stroke or Systemic Embolism, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
- Trial name
- NCT06930937
- Testing
- Lixiana® Film Coated Tablet, Edoxaban Film Coated Tablet
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Pharmacokinetics
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of Oral WCK 2349
The present study is planned to assess the safety, tolerability and pharmacokinetic profile of WCK 2349 in US subjects with selected ascending multiple doses of WCK 2349 and to compare the safety, tolerability and pharmacokinetic…
- Trial name
- NCT04874324
- Testing
- WCK 2349 Oral
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Wockhardt
Bipolar I Disorder
Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Steady State Fasted Conditions
The objective of this study was to prove the bioequivalence of Roxane Laboratories' Quetiapine Fumarate 300 mg Tablet under fasted steady state conditions.
- Trial name
- NCT01570959
- Testing
- Quetiapine Fumarate
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Roxane Laboratories
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