Clinical trials: Single Layer
Healthy Volunteer
Bioequivalence Study of Simvastatin 40 mg Film-coated Tablets in Healthy Thai Volunteers
The goal of this bioequivalence study is to determine and compare the rate and extent of absorption and to evaluate safety of test and reference formulations.
- Trial name
- NCT06178640
- Testing
- Simvastatin 40 mg film-coated tablet, Zocor 40 mg film-coated tablet
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- International Bio service
Type 2 Diabetes
Bioequivalence Study of Test Product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg Film Coated Tablets and Reference Product (R) of Segluromet 7.5 mg/ 1000 mg Film Coated Tablets in Healthy, Adult, Human Subjects Under Fed Condition.
An Open Label, Balanced, Randomized, Single dose, Two treatment, Two sequence, Two period, Two way crossover, Oral Bioequivalence Study of test product (T) of Ertugliflozin/Metformin 7.5 mg/ 1000 mg film coated tablets of Humanis…
- Trial name
- NCT07266779
- Testing
- Ertugliflozin/Metformin film coated tablets, Segluromet film coated tablets
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Epilepsy
Bioequivalence Study of Perampanel Tablets 12 mg
An open-label, balanced, randomized, two treatment, two sequence, two period, two way cross-over, single dose bioequivalence study of Perampanel Tablets 12 mg of Humanis Sağlık A.ġ., Turkey and Fycompa 12 mg film-coated tablets…
- Trial name
- NCT06450223
- Testing
- Perampanel 12 MG, Fycompa 12 mg film-coated tablets
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Hepatitis B
Pharmacokinetics of Two Formulations of Entecavir
A Randomized, Parallel, Single-Dose Study to Evaluate the Pharmacokinetics of a Test Formulation of Entigin Film Coated Tablet 0.5mg (Entecavir 0.5 mg), Compared to an Equivalent Dose of a Reference Drug Product (Baraclude 0.5mg…
- Trial name
- NCT02850848
- Testing
- Entigin Film Coated Tablet 0.5mg, (Baraclude 0.5mg Tablets
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Yung Shin Pharm. Ind. Co., Ltd.
Hypercholesterolaemia
Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Trial name
- NCT07170852
- Testing
- Bempedoic acid film coated tablet, Nilemdo® Film-coated tablets
- Where
- India
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Pulmonary Arterial Hypertension
Bioequivalence Study of Riociguat 2.5 mg Film Coated Tablets and Adempas (Riociguat) 2.5 mg Film Coated Tablets
Single dose oral bioequivalence study of Riociguat 2.5 mg film coated tablets and 'Adempas' (Riociguat) 2.5 mg Filmtabletten (film coated tablets) in healthy adult male subjects under fasting conditions.
- Trial name
- NCT06180096
- Testing
- Riociguat film coated tablets, Adempas Filmtabletten
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy Subjects
Bioequivalence Study Comparing Mucinex Extended-release 600 mg Tablets to Immediate-release Guaifenesin 600 mg in Healthy Volunteers
Determine bioequivalence, safety and tolerability of guaifenesin extended-release 600 mg (Mucinex® SE) compared to an immediate-release syrup reference product in normal healthy subjects.
- Trial name
- NCT03644095
- Testing
- Mucinex® SE, Vicks Cough Syrup for Chesty Coughs
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Pharmacokinetic Analysis, Bioequivalence
Bioequivalence Study of Levetiracetam 1500 mg Coated Granules in Healthy, Male Subjects
Pivotal, single-dose, randomized, open-label, two-period, two-sequence, two-treatment, single-centre, crossover, bioequivalence study of Levetiracetam 1500 mg coated granules in sachet formulations and Keppra (Levetiracetam) 2 x…
- Conditions
- Pharmacokinetic Analysis, Bioequivalence, Health Adult Subjects
- Trial name
- NCT07393022
- Testing
- Levetiracetam 1500 mg, Keppra® 750 mg
- Where
- Canada
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Desitin Arzneimittel GmbH
Bioequivalence
Bioequivalence Study of Rosuvastatin in Healthy Volunteers Under Fasting Condition
The present study is conducted to evaluate and compare the relative bioavailability for Rosuvastatin in two different products containing 10 mg film coated tablet after single oral administration.
- Trial name
- NCT05197517
- Testing
- Rosuvastatin 10 mg
- Where
- Egypt
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Rania Mahmoud Mohamed
Healthy
Bioequivalence Study of Nirmatrelvir & Ritonavir From Copaxid 150 +100 mg Tablets (Eva Pharma, Egypt) Versus Paxlovid 150 + 100 mg Film Coated Tablets (Pfizer Europe, Belgium)
Comparative randomized, single dose, three-way, three-sequence, two treatment, partial replicate, crossover, open-label study to determine the bioequivalence of Nirmatrelvir \& Ritonavir From Copaxid 150 +100 mg Tablets (Eva…
- Trial name
- NCT05491330
- Testing
- Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference first dose), Nirmatrelvir 150 mg + Ritonavir 100 mg (test), Nirmatrelvir 150 mg + Ritonavir 100 mg (Reference second dose)
- Where
- Egypt
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Genuine Research Center, Egypt
Healthy
Study of the Effect of Food Intake on the Bioavailability of XC8 10 mg Film-coated Tablets
Primary objective of the study: evaluation of the effect of food intake on the bioavailability of XC8, film-coated tablets, 10 mg after a single oral administration in fed or fasted condition at a dose of 20 mg (two tablets).
- Trial name
- NCT05294250
- Testing
- XC8
- Where
- Russia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy Participants
A Bioavailability and Food Effect Study of AZD5462 in Healthy Volunteers
This study will assess the pharmacokinetics of AZD5462 film-coated tablet formulation in healthy participants.
- Trial name
- NCT05512806
- Testing
- AZD5462
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Erosive Gastritis, Erosive Esophagitis(EE)
Bioequivalence Study to Compare Vonoprazan 20 mg Film Coated Tablets Versus Voquezna® 20 mg (Vonoprazan) Tablets
Randomized, Single Dose, Two-Way Crossover, Open Label bioequivalence study to compare Vonoprazan 20 mg Film Coated Tablets versus Voquezna® 20 mg (Vonoprazan) Tablets an oral administration to healthy adults under fasting…
- Conditions
- Erosive Gastritis, Erosive Esophagitis(EE), HELICOBACTER PYLORI INFECTIONS
- Trial name
- NCT07278349
- Testing
- Vonoprazan Tablets, VOQUEZNA® Tablets
- Where
- Jordan
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Humanis Saglık Anonim Sirketi
Healthy
A Study in Healthy Humans to Assess the Relative Bioavailability of One Fixed-dose Combination Tablet Empagliflozin/Metformin Versus Jardiance® Tablet and Glifage® Tablet Administered Together
This trial is to establish bioequivalence of the fixed dose combination (FDC) tablets (containing 12.5 mg empagliflozin/850 mg metformin) (Test, T) compared with the single tablets (10 mg empagliflozin and Glifage® 850 mg…
- Trial name
- InPedILD® (NCT05083949)
- Testing
- FDC 12.5mg empagliflozin/850mg metformin, Empagliflozin, Glifage®
- Where
- Brazil
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Surgical Wound Closure Technique
Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
the study is comparing the results of aesthetic surgery wound closure by a single layer versus the traditional multi-layer closure as regards the wound healing time, local wound complications, and the scar formed.
- Trial name
- NCT05166681
- Testing
- surgical wound suturing
- Where
- Egypt
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Abouqir General Hospital
Bioequivalence, Healthy Subjects
Bioequivalence Study of Test and Reference 400 mg Ibuprofen Coated Tablets in Healthy Volunteers
This study is a comparative bioavailability study performed to assess bioequivalence between Test medicinal product (Darfen 400, 400 mg ibuprofen coated tablets [512 mg ibuprofen sodium dihydrate], manufactured by PrJSC…
- Trial name
- NCT05663398
- Testing
- Darfen 400, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate), Nurofen® Forte Express, 400 mg ibuprofen coated tablets (512 mg ibuprofen sodium dihydrate)
- Where
- Jordan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Darnitsa Pharmaceutical Company
Healthy
Bioavailability of BIBR 953 ZW After Dose of BIBR 1048 MS
To assess the extent of absorption of 12.5, 50 and 200 mg of BIBR 1048 MS with and without coadministration of 150 mg ranitidine.
- Trial name
- NCT02170792
- Testing
- BIBR 1048 MS, Ranitidine
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body
The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894 and its metabolites, total radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of [14C]…
- Trial name
- NCT04567316
- Testing
- [14C]-radiolabelled BI 1358894, BI 1358894
- Where
- Netherlands
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Bioequivalence
A Bioequivalence Study of Two Different Formulations of Olmesartan Medoxomil/ Hydrochlorothiazide After a Single Oral Dose Administration Under Fasting Conditions
This single dose study was designed in accordance with EMA (the European Medicines Agency) regulatory guidelines, with the aim of characterizing the bioavailability of olmesartan medoxomil/ hydrochlorothiazide in the two…
- Trial name
- NCT04138888
- Testing
- Olmesartan Medoxomil/Hydrochlorothiazide 40 Mg/25 Mg film-coated tablets for oral use, Olmetec® Plus 40 Mg/25 Mg film-coated tablets for oral use
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pharmtechnology LLC