Clinical trials: Fasting Period
Bioequivalence
Bioequivalence Study of Two Formulations of Tablets Ramipril 10 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Tritace®, 10 mg tablets) or the test (Ramipril, 10 mg tablets)…
- Trial name
- NCT05438316
- Testing
- Ramipril tablet 10 mg, Tritace® tablet 10 mg
- Where
- Russia
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Volunteer, Dabigatran
Bioequivalence Study of Dabigatran Etexilate Capsules 150 mg in Healthy Thai Volunteers Under Fasting Conditions
The bioequivalence of Dabigatran Etexilate Capsules 150 mg to Boehringer Ingelheim's Pradaxa® will be assessed by a statistical comparison of various pharmacokinetic parameters derived from the plasma concentration-time curves of…
- Conditions
- Healthy Volunteer, Dabigatran, Bioequivalence Study
- Trial name
- NCT06441916
- Testing
- Dabigatran Etexilate Capsules 150 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- International Bio service
Healthy
Fasting Study of Controlled-Release Oxycodone Hydrochloride 40 mg Tablets and OxyContin® 40 mg Tablets
The objective of this open-label, randomized, two-period, crossover study was to evaluate the oral bioavailability of the Mallinckrodt controlled-release test tablet formulation of oxycodone 40 mg compared to an equivalent oral…
- Trial name
- NCT00853892
- Testing
- Controlled-Release Oxycodone Hydrochloride 40 mg tablet, OxyContin® 40 mg tablet
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Fasting
Bioequivalence Study of Metoprolol Succinate Extended Release Tablets 200 mg Under Fasting Conditions
This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover, balanced, single dose pivotal study. The purpose of this study is to assess the bioequivalence between Test Product and the corresponding…
- Trial name
- NCT01884896
- Testing
- Metoprolol Succinate ER Tablet 200 mg, 'TOPROL-XL®' ER Tablets 200 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Bioequivalence Study of Ramipril 10 mg Capsules Under Fasting Conditions
The study was conducted as an open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioavailability study comparing Ramipril capsules 10 mg of OHM Laboratories Inc., USA with ALTACE®…
- Trial name
- NCT00879476
- Testing
- Ramipril 10mg capsules
- Where
- India
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Pain
Pharmacokinetic and Comparative Bioavailability Study of Codeine Sulfate Under Fasted Conditions
The objective of this study designed to characterize the pharmacokinetics and comparative bioavailability of Roxane Laboratories' codeine sulfate tablets after oral administration of 60 mg doses as 1 x 60 mg, 2 x 30 mg and 4 x 15…
- Trial name
- NCT01010139
- Testing
- Codeine Sulfate
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Hyperlipidemia
A 12 Week, 3-Period Study to Evaluate the Effects of a Dietary Supplement on Lipid Metabolism
This study will evaluate the effects of encapsulated botanical extracts, previously shown to inhibit the enzyme diacylglycerol-acyltransferase-1 (DGAT-1) in vitro, on fasting and postprandial lipid metabolism during an oral fat…
- Trial name
- NCT02366156
- Testing
- Low Dose Grape Blend, High Dose Grape Blend
- Where
- United States
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Access Business Group
Diabetes, Diabetes Mellitus
Phase 1 Study in Diabetes Mellitus(Fasting)
An open-label, randomized, fasting, single-dose, 2-sequence, 2-period, crossover phase 1 study in healthy volunteers.
- Trial name
- NCT06552182
- Testing
- HUC2-344, HUC2-344-R1, HUC2-344-R2
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Huons Co., Ltd.
Fasting
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 42 (+ 4 standby)…
- Trial name
- NCT01283919
- Testing
- Pantoprazole Sodium
- Where
- India
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories 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
Healthy
Fasting Study of Oxycodone Hydrochloride 30 mg Tablets and Roxicodone™ 30 mg Tablets
The objective of this open-label, randomized, two-period crossover study was to compare the oral bioavailability of a Mallinckrodt test tablet formulation of oxycodone 30 mg to an equivalent oral dose of a commercially available…
- Trial name
- NCT00853216
- Testing
- Oxycodone hydrochloride tablet 30 mg, Roxicodone™ tablet 30 mg
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Bioequivalence
Bioequivalence Study of Two Formulations of Rivaroxaban Tablets 10 mg in Healthy Male Volunteers in Fasting Conditions
This is an open-labeled, laboratory-blinded, randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Xarelto®, 10 mg film-coated tablets) or the test…
- Trial name
- NCT04753489
- Testing
- Rivaroxaban film-coated tablet 10 mg, Xarelto® film-coated tablet 10 mg
- Where
- Russia
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Bioequivalence
Bioequivalence Study of Two Formulations of Lisinopril Tablet 20 mg in Healthy Volunteers Under Fasting Conditions
This is an open-labeled (laboratory blinded), randomized, two period, single-center, crossover, comparative study, where each participant will be randomly assigned to the reference (Zestril®, 20 mg) or the test (Lisinopril, 20…
- Trial name
- NCT05061901
- Testing
- Lisinopril tablet 20 mg, Zestril® tablet 20 mg
- Where
- Russia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC
Healthy Volunteers in Fed and Fasted State
In-clinic Crossover Study in Subjects With Two Treatments (Fed vs Fasted)
The primary purpose of this study is to assess the effect of food on the rate and extent of absorption and the overall bioavailability of a single dose of CTx-1301 50 mg trimodal tablets in healthy adult volunteers.
- Trial name
- Fed-Fast (NCT07119073)
- Testing
- Dexmethylphenidate
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Cingulate Therapeutics
Breast Cancer
Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions
The objective of this study was to prove the bioequivalence of Anastrozole Tablet under fasted conditions.
- Trial name
- NCT01155102
- Testing
- Anastrozole
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Roxane Laboratories
Bioequivalence
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, 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 (NCT04406194)
- Testing
- FAVICOVIR 200 mg Film Tablet, AVIGAN 200 mg Film Tablets
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Atabay Kimya Sanayi Ticaret A.S.
Healthy Adult Subjects
A Comparative Pharmacokinetic Study of ADL-018 Autoinjector Compared to A Pre-filled Syringe in Healthy Subjects.
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): ADL-018 Injection 150 mg/mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference…
- Trial name
- NCT06929052
- Testing
- ADL-018 Autoinjector, ADL-018 Injection
- Where
- Canada
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Healthy
Bioequivalence Study of Fexofenadine Hydrochloride Orally Disintegrated Tablets 30 mg Under Fasting Condition
To assess the bioequivalence of Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg of Dr. Reddy's Laboratories Limited, India comparing with that of Allegra® (containing fexofenadine hydrochloride) Orally…
- Trial name
- NCT01888718
- Testing
- Fexofenadine Hydrochloride
- Where
- India
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Chronic Obstructive Pulmonary Disease
A Trial to Assess the Bioequivalence of Generic Tiotropium Bromide Inhalation Powder and Reference Product in Healthy Adult Participants Under Fasting Conditions (Pilot)
Primary Objective: To evaluate the pharmacokinetics of Tiotropium Bromide Inhalation Powder (Strength:18 mcg; manufactured by Chia Tai Tianqing Pharmaceutical Group Co.
- Trial name
- NCT06326671
- Testing
- Tiotropium Bromide Inhalation Powder, Spiriva HandiHaler
- Where
- China
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy Volunteer Male Subjects
A Comparative Bioavailability Study of Tamsulosin 0.4 mg Prolonged-release Tablets Versus the Reference Drug Omnic Ocas®, Tamsulosin Hydrochloride 0.4 mg, Prolonged-release Film-coated Tablets, in Healthy Adult Male Subjects, Under Fasting Conditions
The aim of this study is to evaluate the bioequivalence and safety of Tamsulosin hydrochloride 0.4 mg, prolonged-release tablets (Synthon Hispania SL, Spain), compared to Omnic Ocas®, Tamsulosin hydrochloride 0.4 mg…
- Trial name
- NCT07156916
- Testing
- Tamsulosin (0.4 mg/j)
- Where
- Armenia
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Berlin-Chemie AG Menarini Group