Clinical trials: Normal Healthy
To Determine Bioequivalence Under Fed Conditions
The Study Aims to Show Bioequivalence of the Test Product and the Reference Reference Product in a Crossover Design Study Healthy Volunteers. Additionally, the Safety Profile of Test Product Compared to Reference Product Will be Assessed.
To evaluate and compare the relative bioavailability and therefore the bioequivalence of fixed dose combination of Metformin and Vildagliptin Tablets 850/50 mg manufactured by Oman Pharmaceuticals Products Co.
- Trial name
- NCT05337969
- Testing
- Metformin and Vildagliptin 850/50 mg
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- AET Laboratories Private Limited
Dermatitis, Atopic, Eczema, Infantile
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.
- Conditions
- Dermatitis, Atopic, Eczema, Infantile, Infant Development, Child Development
- Trial name
- GIraFFE (NCT04599946)
- Testing
- Infant formula and follow-on formula made from whole goat milk, Infant formula and follow-on formula made from cow's milk ingredients
- Where
- 12 sites in Germany, Poland and 1 more
- Volunteers
- 2,132 people, healthy volunteers welcome
- Sponsor
- Dairy Goat Co-operative (N.Z.) Limited
Normal Healthy Volunteers
Lofexidine Mass Balance in Volunteers
The purpose of this study is to see how lofexidine (investigational study formulation drug) is absorbed, broken down, and removed from the body.
- Trial name
- NCT01629446
- Testing
- Lofexidine hydrochloride
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
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.
Normal Hepatic Function, Impaired Hepatic Function
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as…
- Trial name
- NCT02388620
- Testing
- LEE011
- Where
- 3 sites in United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
Study of CAD-9303 in Subjects With Schizophrenia
This study will consist of Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) cohorts that will be randomized, double-blind, and placebo-controlled to assess the safety, tolerability, and pharmacokinetics of CAD-9303.
- Trial name
- Affinity-1 (NCT04306146)
- Testing
- CAD-9303
- Where
- 2 sites in United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Cadent Therapeutics
Primary Hyperoxaluria
Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria
This is a double-blind, placebo-controlled, dose escalation trial of DCR-PHXC in Healthy Volunteers (HVs) and patients with Primary Hyperoxaluria (PH).
- Trial name
- NCT03392896
- Testing
- DCR-PHXC
- Where
- 7 sites in United States, France and 3 more
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Fasting
Bioequivalence Study of Metformin Hydrochloride Extended-Release Tablets USP 750 mg Under Fed Condition
The study was a randomized, open label, two-treatment, two-period, two-sequence, single dose, crossover, oral bioequivalence study in normal, healthy adult human subjects under fed condition.
- Trial name
- NCT01831674
- Testing
- Metformin Hydrochloride Extended-Release Tablets USP 750, GLUCOPHAGE®XR tablet 750 mg
- Where
- India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- IPCA Laboratories Ltd.
Healthy
Estradiol/Norethindrone Acetate Tablets, 1/0.5 mg Under Fasting Conditions
The objective of this study was to determine and compare the rate and extent of absorption of norethindrone and unconjugated estradiol from a test formulation of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg versus the…
- Trial name
- NCT01157182
- Testing
- Estradiol/Norethindrone acetate, Activella®
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Psoriasis
An Ascending Multiple Dose Study With VTP-43742 in Healthy Volunteers and Psoriatic Patients
This is a two-part, randomized, double-blind, placebo-controlled study in which VTP-43742 will be administered to normal healthy volunteers (NHV) and to moderate to severe psoriatic patients, both in sequential ascending dose…
- Trial name
- NCT02555709
- Testing
- VTP-43742
- Where
- 14 sites in United States
- Volunteers
- 74 people, healthy volunteers welcome
- Sponsor
- Vitae Pharmaceuticals Inc., an Allergan affiliate
Diabetes Mellitus, Type 2
Study to Determine the Utility of Novel Technologies and Biomarkers to Measure Human Response to Rosiglitazone Maleate
Insulin resistance (IR) is common in many metabolic disorders and predisposes an individual to Type 2 Diabetes Mellitus (T2DM), the Metabolic Syndrome and coronary atherosclerosis.
- Trial name
- NCT00551564
- Testing
- rosiglitazone maleate
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Formulation Bridging, Food Effect
A Formulation Bridging and Food Effect Study of PBI-200 in Healthy Volunteers
This is a single-dose, two-part, crossover formulation bridging and food effect study to assess the effect of formulation and food on the absorption and bioavailability of PBI-200 in normal, healthy volunteers.
- Trial name
- NCT05690932
- Testing
- PBI-200 Tablet, PBI-200 Capsule, PBI-200 Suspension
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Pyramid Biosciences
Herpes Simplex
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.
- Trial name
- NCT00698893
- Testing
- Herpes simplex candidate (gD) vaccine GSK208141
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hypertension
An Comparative Pharmacokinetic Study of Amlodipine Besylate Controlled-release Tablets,China in Normal, Healthy, Adult, Human Subjects Under Fasting Conditions
Amlodipine Besylate Controlled-release Tablets in Healthy Volunteers in a Randomized, Open, Two-cycle, Double-cross, Fasting State Comparative Pharmacokinetic Study.
- Trial name
- NCT05667818
- Testing
- Amlodipine besylate tablets (trade name: Norfloxacin ®）, Amlodipine besylate controlled-release tablets
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Overseas Pharmaceuticals, Ltd.
Healthy, Dermatitis, Atopic
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis (AtD).
- Trial name
- NCT05486208
- Testing
- LY3844583
- Where
- 3 sites in United States, Japan
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Bioequivalence
Bioequivalence Study of Metformin 750 mg Tablets XR Versus Glucophage® Long 750 mg Tablets XR In Normal Healthy Subjects Under Fasting and Fed Conditions
Bioequivalence Study of 2 formulation of metformin (Metformin GEROPHARM vers. Glucophage® Long Merck )
- Trial name
- NCT03452306
- Testing
- Metformine, Glucophage® Long, Metformin
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Geropharm
Psoriasis, Arthritis, Psoriatic
Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation
The main objective of this study is to compare the relative bioavailability, safety, and tolerability of extended-release and immediate-release apremilast formulations in healthy participants.
- Conditions
- Psoriasis, Arthritis, Psoriatic, Oral Ulcer
- Trial name
- NCT07908641
- Testing
- Apremilast XR, Apremilast IR
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Amgen
Breast Cancer
The Perspective of Healthy Individuals on Breast Cancer Risk Prediction Report In The Indonesian Population
In 2016, a meta-analysis showed that DNA-based risk reporting alone does not facilitate behavior change. However, there have been several studies showing that tailoring care plans related to diet may help with adherence to a…
- Trial name
- PERCEPTION (NCT05562440)
- Testing
- Focus Group Discussion
- Where
- Indonesia
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Nalagenetics Pte Ltd
Atopic Dermatitis
Phase I Study of DS-2741a in Healthy Volunteers and Participants With Atopic Dermatitis
This is a phase 1, single-center, first-in-human study to assess the safety, pharmacokinetics and pharmacodynamics of DS-2741a after subcutaneous injection in healthy Japanese male volunteers and Japanese participants with…
- Trial name
- NCT04211415
- Testing
- DS-2741a
- Where
- Japan
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Daiichi Sankyo Co., Ltd.
Nutritional Deficiency
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by…
- Trial name
- NCT00950976
- Testing
- citrulline, Lemonade
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Société des Produits Nestlé (SPN)
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