Clinical trials: Drug Dose
Hypolactasia
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)
The study primary objective is to compare the clinical efficacy of two formulations in the supportive treatment of lactose intolerance.
- Trial name
- EF099 (NCT01145339)
- Testing
- Lactase
- Where
- 7 sites in Brazil
- Volunteers
- 140 people
- Sponsor
- Eurofarma Laboratorios S.A.
Drug-drug Interaction
A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects
This drug-drug interaction study will evaluate the impact of two different acid reducing agents (from two different drug classes) co-administered with a single dose of telotristat ethyl.
- Trial name
- NCT03302845
- Testing
- Omeprazole 40 MG, Famotidine 40 mg, Telotristat ethyl 250 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lexicon Pharmaceuticals
Grade I or II Essential Hypertension
Study to Evaluate the Efficacy and Safety of Combined Administration of TAK-536CCB and Hydrochlorothiazide in Patients With Grade I or II Essential Hypertension.
The objective of this study is to compare the efficacy and safety of combined administration of TAK-536CCB (Fix-dose combination of Azilsartan and Amlodipine) and Hydrochlorothiazide (HCTZ) with those of TAK-536CCB in patients…
- Trial name
- NCT02072330
- Testing
- TAK-536CCB, TAK-536CCB + Hydrochlorothiazide, Hydrochlorothiazide
- Where
- 13 sites in Japan
- Volunteers
- 353 people
- Sponsor
- Takeda
Pharmacokinetics, Pharmacodynamics
Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-NS250 and IY-NT-SR
This study comparative evaluation of safety and pharmacokinetic and pharmacodynamic properties in oral repeat administration of IY-NS250 and IY-NT-SR in healthy adult
- Trial name
- NCT06725992
- Testing
- IY-NS250, IY-NT-SR
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Diabetic Neuropathies
Efficacy and Safety Study of TAK-128 in Treating Subjects With Diabetic Peripheral Neuropathy
The purpose of this study is to determine the efficacy and safety of TAK-128, once daily (QD), in treating subjects with diabetic peripheral neuropathy.
- Trial name
- NCT00229437
- Testing
- TAK-128
- Where
- 48 sites in United States, Canada
- Volunteers
- 343 people
- Sponsor
- Takeda
Treatment Resistant Depression
A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)
This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major…
- Trial name
- NCT06524830
- Testing
- VLS-01-203 BU
- Where
- 48 sites in United States, Australia and 2 more
- Volunteers
- 142 people
- Sponsor
- atai Therapeutics, Inc.
Healthy Volunteer
A Study to Assess Multiple Ascending Dose, Drug-Drug Interaction, and Asian Pharmacokinetic Study of ABBV-1088
This study will assess the safety, tolerability, and pharmacokinetics of ABBV-1088 in healthy adult Western, Han-Chinese and Japanese participants.
- Trial name
- NCT06579300
- Testing
- ABBV-1088, Itraconazole (ITZ)
- Where
- 2 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AbbVie
Diabetes, Diabetes Mellitus, Type 2
A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump
This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Delivery Systems
- Trial name
- NCT00115973
- Testing
- pump, insulin aspart
- Where
- 6 sites in United States
- Volunteers
- 71 people
- Sponsor
- Novo Nordisk A/S
Healthy
Fasting Study of Hydromorphone Hydrochloride 8 mg Tablets and Dilaudid 8 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 hydromorphone 8 mg to an equivalent oral dose of a commercially…
- Trial name
- NCT00853554
- Testing
- Hydromorphone Hydrochloride tablet 8 mg, Dilaudid® tablet 8 mg
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mallinckrodt
Friedreich Ataxia
Efficacy, Tolerability, and Pharmacokinetics of Multiple Doses of Oral TAK-831 in Adults With Friedreich Ataxia
The purpose of this study is to evaluate the efficacy of TAK-831 versus placebo on upper extremity (arm and hands) motor function and manual dexterity.
- Trial name
- NCT03214588
- Testing
- TAK-831
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neurocrine Biosciences
Solid Tumor, Advanced Solid Tumor
A Study of XB628 Alone and in Combination With Zanzalintinib in Participants With Recurrent Advanced or Metastatic Solid Tumors
This study consists of a Dose-Escalation stage and a Dose Expansion stage. The primary purpose of the dose escalation stage is to determine the maximum tolerated dose (MTD) and/or recommended dosage(s) for expansion (RDE[s]); and…
- Conditions
- Solid Tumor, Advanced Solid Tumor, Metastatic Solid Tumor, Immune Sensitive Tumor
- Trial name
- NCT06952010
- Testing
- XB628, Zanzalintinib
- Where
- 11 sites in United States
- Volunteers
- 303 people
- Sponsor
- Exelixis
Contraception
Estetrol (E4)/Drospirenone (DRSP) Drug-drug Interaction (DDI) Study
The present study is designed to determine the effect of valproic acid (VAL), a UGT2B7 inhibiting drug, on the pharmacokinetics (PK) of estetrol (E4)
- Trial name
- NCT03512860
- Testing
- E4/DRSP, VAL
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Estetra
Hypertension
Drug-drug Interaction Study (Telmisartan, Amlodipine, Chlorthalidone)
To evaluate Drug-drug interaction
- Trial name
- NCT02152969
- Testing
- Telmisartan, Amlodipine, Chlorthalidone
- Where
- South Korea
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Primary Hypogonadism, Hypogonadotropic Hypogonadism
Bioequivalence Study of Test and Reference Testosterone Topical Gel, 1.62% Metered Pump in Testosterone Deficient Adult Male Subjects Under Fasting Conditions
Bioequivalence study comparing the rate and extent of testosterone absorption for a test formulation versus the reference product.
- Trial name
- NCT02110368
- Testing
- Testosterone Topical Gel, 1.62% Metered Pump, AndroGel (testosterone gel) 1.62% Metered-Dose Pump
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Amneal Pharmaceuticals, LLC
Advanced Non-hematologic Malignancies
A Phase 1 Study of IXAZOMIB in Adult Patients With Advanced Nonhematologic Malignancies
This is an open-label, multicenter, phase 1, dose escalation study of IXAZOMIB. The primary purpose of this study is to determine the safety profile, establish the maximum tolerated dose, and inform the phase 2 dose of IXAZOMIB…
- Trial name
- NCT00830869
- Testing
- IXAZOMIB
- Where
- 7 sites in United States, Canada
- Volunteers
- 116 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Drug Interaction
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport
This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in healthy subjects.
- Trial name
- NCT05334108
- Testing
- Ecopipam, Cohort 1 Probe Substrate Cocktail, Cohort 2 Probe Substrate
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Emalex Biosciences Inc.
Major Depressive Disorder
A Study of LY03005 vs Pristiq
The objective of this study is to evaluate relative bioavailability between 80 mg LY03005 oral tablets and 50 mg Pristiq® oral tablets after a single dose of each drug in a cross-over 2-period design under fasting condition in…
- Trial name
- NCT03733574
- Testing
- LY03005, Pristiq
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Healthy Subjects
First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders
The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy male adults
- Trial name
- NCT02719197
- Testing
- AC-083
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Coronavirus Disease
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Efficacy of TAK-671 for the Treatment of Coronavirus Disease (COVID) 2019 in Adults
The purpose of this study is to assess safety, tolerability, preliminary efficacy, and PK of TAK-671 in participants with COVID-19.
- Trial name
- NCT04464460
- Testing
- TAK-671
- Sponsor
- Takeda
Bilateral Cataract
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
Each patient will be randomized to receive one dose of the test article in one eye and one dose of the reference formulations in the contralateral eye.
- Trial name
- TBO (NCT02734459)
- Testing
- cataract surgery
- Volunteers
- 756 people
- Sponsor
- Semler Research Center Pvt. Ltd.