Clinical trials: Single Layer
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
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
Heartburn
A Study to Assess the Bioequivalence of Famotidine Chewable Tablets and Film-Coated Tablets (0208-144)
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation.
- Trial name
- NCT00945750
- Testing
- Famotidine FCT, Famotidine CT
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Ridge Preservation
To Compare Ridge Preservation Technique Using Leukocyte Platelet Rich Fibrin (L-PRF) and Freeze-dried Bone Allograft (FDBA) Layered Technique vs L-PRF/FDBA and L-PRF Alone in Influencing Quantity and Quality of New Bone Formation in Grafted Extraction Sockets
This study will evaluate the effect of Leukocyte Platelet Rich Fibrin and freeze-dried bone allograft in a layered technique on the bone quantity and quality following socket grafting in preparation for endosseous implant…
- Trial name
- NCT04133363
- Testing
- Ridge preservation using L-PRF/FDBA layered technique, Ridge preservation using L-PRF/FDBA, Ridge preservation using L-PRF
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Irritable Bowel Syndrome, Abdominal Pain
Comparing a 182mg Colon-targeted-delivery Peppermint Oil Capsule (Tempocol-ColoPulse®) and a 182mg Enteric-coated Peppermint Oil Capsule (Tempocol®), a Pharmacokinetic Study
This is a pilot study to compare the relative bioavailability between two peppermint oil formulations, namely a ileocolonic release peppermint oil and an small intestinal release peppermint oil (Tempocol®).
- Conditions
- Irritable Bowel Syndrome, Abdominal Pain, Colonic Diseases, Visceral Pain
- Trial name
- NCT02291445
- Testing
- Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule), Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)
- Where
- Netherlands
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Maastricht University Medical Center
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 Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Diabetes Mellitus, Type 2
OXEMET™ 1000 mg Coated Tablets (Metformin Hydrochloride) Bioequivalence Study. OXEMET (TM) is a Trademark of the GlaxoSmithKline Group of Companies. GLAFORNIL(TM) is a Trademark of Merck.
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under…
- Trial name
- NCT01842620
- Testing
- Metformin
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
To assess the relative bioavailability of ALXN1840 administered orally as a single enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment B).
- Trial name
- NCT05303324
- Testing
- ALXN1840
- Where
- United Kingdom
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
Bioequivalence Study of Coated Cesol Tablet Formulation Versus Biltricide
The purpose of this study is to assess the bioequivalence (BE) of new coated Cesol tablet (Test) versus Biltricide tablets (Comparator) in healthy male participants.
- Trial name
- NCT04314037
- Testing
- Cesol (Test), Biltricide (Reference)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Infections, Urinary Tract
A Bioequivalence Study of Cefadroxil Film Coated Tablets After A Single Oral Dose Administration to Healthy Subjects
This is an open-label, randomized, single dose, two-sequence two-period crossover study, separated by 7 days washout interval from the first Study Drug Administration.
- Trial name
- NCT02446496
- Testing
- Cefadroxil tablets manufactured by GSK, Cefadroxil tablets manufactured by NP
- Where
- Egypt
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Participants
A Study to Learn How the Body Processes Spironolactone and Hydrochlorothiazide Film Coated Tablets Manufactured at Two Sites: Viatris and Neolpharma
The purpose of the study is to understand how the body processes Spironolactone and Hydrochlorothiazide after taking Spironolactone and Hydrochlorothiazide film coated tablets manufactured at two sites: Viatris and Neolpharma by…
- Trial name
- NCT06205407
- Testing
- Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Viatris, Spironolactone/Hydrochlorothiazide (25 mg/25 mg) film coated tablets from Neolpharma.
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline…
- Trial name
- NCT01235195
- Testing
- sertraline hydrochloride
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Healthy
A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.
- Trial name
- NCT05319912
- Testing
- ALXN1840 Enteric-coated Tablet, ALXN1840 Non-coated Capsule, Omeprazole
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Volunteers
Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects
Primary objective To demonstrate the bioequivalence of a fixed dose combination tablet containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl vs.
- Trial name
- NCT02963701
- Testing
- Ibuprofen, Pseudoephedrine-HCl
- Where
- South Africa
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Anti-Psychotic, Management of Manifestations of Psychotic Disorders
Assessment of Intra-subject Variability in the Bioavailability of Chlorpromazine Hydrochloride
Cycle Pharmaceuticals Ltd. (Cycle) is developing an oral tablet formulation of Chlorpromazine Hydrochloride and intends to conduct bioequivalence trials to demonstrate its similarity to the RLD.
- Conditions
- Anti-Psychotic, Management of Manifestations of Psychotic Disorders, Treatment of Schizophrenia, Control Nausea and Vomiting
- Trial name
- NCT02943213
- Testing
- Chlorpromazine Hydrochloride
- Where
- South Africa
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cycle Pharmaceuticals Ltd.
Healthy Subjects
Study to Evaluate the Pharmacokinetics of Mucinex® 1200 mg Extended-Release Tablet
Characterize and assess PK of guaifenesin in Mucinex® 1200 mg ER Bi-Layer Tablet
- Trial name
- NCT03633487
- Testing
- Mucinex®
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser LLC
Uterine Scar, Cesarean Section Complications
Single or Double-layer Uterine Closure Techniques
There are different surgical techniques of uterine closure during cesarean. A growing data has suggested that the closure technique has an effect on uterine scar healing.
- Conditions
- Uterine Scar, Cesarean Section Complications, Cesarean Section; Dehiscence
- Trial name
- NCT03629028
- Testing
- Residual myometrium thickness, Niche Presence, Adjacent myometrium thickness
- Where
- Turkey (Türkiye)
- Volunteers
- 282 people, healthy volunteers welcome
- Sponsor
- Safak Baran Yilmaz
Healthy Volunteers
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin enteric-coated tablet 100 mg in Japanese healthy adult men…
- Trial name
- NCT03456960
- Testing
- TAK-438ASA, TAK-438, Aspirin
- Where
- Japan
- Volunteers
- 276 people, healthy volunteers welcome
- Sponsor
- Takeda
Helicobacter Pylori Infection
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
This phase Ⅰb/Ⅱa, single-center, randomized, open-label study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy in asymptomatic subjects with…
- Trial name
- NCT06076681
- Testing
- TNP-2198, Rabeprazole Sodium, Amoxicillin
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited