Clinical trials: Medication Safety
Area Under Curve, Pharmacokinetics
The Safety and Pharmacokinetics of Primapur and Gonal-f
The purpose of the current phase I study was to establish bioequivalence, safety, and tolerance of single 300 IU subcutaneous dose of follitropin alfa biosimilar (Primapur) in comparison to that of reference follitropin alfa…
- Conditions
- Area Under Curve, Pharmacokinetics, Absorption
- Trial name
- NCT03857230
- Testing
- Follitropin alfa (Primapur), Follitropin alfa (Gonal-F)
- Where
- Russia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- IVFarma LLC
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2)
A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy
The main aims of the study are: To check for side effects from TAK-994 and check what dose of TAK-994 participants can tolerate. To check what dose range provides adequate relief of narcolepsy symptoms.
- Trial name
- NCT04096560
- Testing
- TAK-994
- Where
- 78 sites in United States, Canada and 10 more
- Volunteers
- 97 people
- Sponsor
- Takeda
Endometrial Cancer
SYD985 in Patients With HER2-expressing Recurrent, Advanced or Metastatic Endometrial Carcinoma
The purpose of this study is to evaluate the safety and efficacy of SYD985 in recurrent, advanced or metastatic endometrial cancer.
- Trial name
- NCT04205630
- Testing
- SYD985
- Where
- 36 sites in United States, Poland and 5 more
- Volunteers
- 64 people
- Sponsor
- Byondis B.V.
Adverse Effects
The Pharmacokinetics of 4% Lidocaine Gel When Applied Topically to the Breasts
The purpose of this study is to test the hypothesis that one-time application of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for pre-medication to reduce discomfort during screening…
- Trial name
- NCT00925353
- Testing
- 4% lidocaine gel
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Mountain States Tumor and Medical Research Institute
ECG, Pharmacokinetics
Evaluating QTc, PK, Safety of Gemtuzumab Ozogamicin (GO) in Patients With CD33+ R/R AML
This is a single-arm, open-label, Phase 4 study evaluating the effect of GO on the QTc, pharmacokinetics, safety, and immunogenicity of GO as a single-agent monotherapy in adult and pediatric patients with relapsed or refractory…
- Conditions
- ECG, Pharmacokinetics, Safety
- Trial name
- NCT03727750
- Testing
- Gemtuzumab Ozogamicin
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 51 people
- Sponsor
- Pfizer
Insomnia, Attention Deficit Hyperactivity Disorder
Safety & Efficacy Study of Study Drug (Eszopiclone) in Children and Adolescents With Attention-deficit/Hyperactivity Disorder - Associated Insomnia
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention…
- Trial name
- NCT00856973
- Testing
- eszopiclone
- Where
- 73 sites in United States
- Volunteers
- 486 people
- Sponsor
- Sumitomo Pharma America, Inc.
Diabetes Mellitus, Type 2
Study to Compare the Efficacy and Safety of Administration of the Fix Dose Combination of Linagliptin Plus Metformin in Drug naïve Type 2 Patients
Reduced factorial design study with 24 week randomized treatment of initial combination therapy with linagliptin and metformin in T2DM patients
- Trial name
- NCT01708902
- Testing
- linagliptin2.5mg/metformin1000mg, linagliptin 5mg, Metformin 500mg
- Where
- 56 sites in China, Malaysia and 2 more
- Volunteers
- 876 people
- Sponsor
- Boehringer Ingelheim
Alzheimer's Disease, Huntington's Disease
A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users
Dimebon will not exhibit abuse potential when compared to placebo or a positive control (alprazolam).
- Trial name
- NCT00975481
- Testing
- dimebon, alprazolam
- Volunteers
- 36 people
- Sponsor
- Pfizer
Diabetes Mellitus, Type 2
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
The objective of the current study is to investigate the safety and tolerability of BI 1356 (5 mg / once daily) given for 78 weeks in different modalities of treatment.
- Trial name
- NCT00736099
- Testing
- linagliptine 5 mg, linagliptine 5 mg and pioglitazone 30 mg
- Where
- 232 sites in United States, Argentina and 30 more
- Volunteers
- 2,122 people
- Sponsor
- Boehringer Ingelheim
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Obesity
Clinical Trial of Safety and Efficacy of Various Dosage Schedules for Dietressa Drug in Treatment of Obese Patients
The purpose of this study is: To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients.
- Trial name
- NCT01535014
- Testing
- Dietressa
- Where
- 17 sites in Russia
- Volunteers
- 493 people
- Sponsor
- Materia Medica Holding
Ulcer
Efficacy and Safety Study of HZT-501 in Subjects Requiring Nonsteroidal Anti-Inflammatory Drug (NSAID) Treatment
The purpose of this study is to evaluate whether HZT-501 is effective in reducing the rate of development of ibuprofen-associated ulcers in patients who require long-term daily use of ibuprofen.
- Trial name
- NCT00450216
- Testing
- Ibuprofen/famotidine, Ibuprofen
- Volunteers
- 906 people
- Sponsor
- Amgen
Depressive Disorder, Major
Efficacy and Safety Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive Disorder
The purpose of this study is to assess the efficacy and safety of multiple doses of vortioxetine, once daily (QD), in participants with major depressive disorder.
- Trial name
- NCT01255787
- Testing
- Vortioxetine
- Where
- 70 sites in Croatia, Finland and 14 more
- Volunteers
- 600 people
- Sponsor
- Takeda
Rheumatoid Arthritis
ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis
This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associated with the use of a…
- Trial name
- NCT01791205
- Where
- 28 sites in Italy
- Volunteers
- 304 people
- Sponsor
- Hoffmann-La Roche
Antipsychotic-induced Weight Gain (AIWG)
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic…
- Trial name
- NCT04524403
- Testing
- Miricorlilant
- Where
- 40 sites in United States
- Volunteers
- 150 people
- Sponsor
- Corcept Therapeutics
Multi-drug Resistant Tuberculosis, Extensively Drug Resistant Tuberculosis
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
This study evaluated the safety and tolerability of low-dose linezolid (600 mg once daily) administered for 16 weeks as part of an optimized background regimen for the treatment of multidrug-resistant tuberculosis (MDR-TB).
- Trial name
- LiMiT (NCT00664313)
- Testing
- Linezolid
- Where
- South Africa
- Volunteers
- 36 people
- Sponsor
- Centers for Disease Control and Prevention
Asthma
A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in…
- Trial name
- NCT06261957
- Testing
- Salbutamol HFA-134a, Salbutamol HFA-152a
- Where
- 102 sites in United States, Argentina and 11 more
- Volunteers
- 471 people
- Sponsor
- GlaxoSmithKline
Rheumatoid Arthritis
A Study to Investigate Safety, Tolerability, and PK of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis
The study is to evaluate the safety, tolerability, and pharmacokinetic (PK) of multiple orally administered TCK-276 in both males and females with Rheumatoid Arthritis (RA).
- Trial name
- NCT05437419
- Testing
- TCK-276
- Where
- 8 sites in United States
- Volunteers
- 32 people
- Sponsor
- Teijin America, Inc.
Atrial Fibrillation (AF)
Study to Gather Information About the Proper Dosing of the Oral FXIa Inhibitor BAY 2433334 and to Compare the Safety of the Study Drug to Apixaban, a Non-vitamin K Oral Anticoagulant (NOAC) in Patients With Irregular Heartbeat (Atrial Fibrillation) That Can Lead to Heart-related Complications.
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give to participants and to look at how well BAY 2433334 works in patients with irregular heartbeat (atrial fibrillation) that can lead to…
- Trial name
- PACIFIC-AF (NCT04218266)
- Testing
- BAY2433334, Apixaban
- Where
- 93 sites in Austria, Belgium and 12 more
- Volunteers
- 755 people
- Sponsor
- Bayer
Obesity
Clinical Trial of Safety and Efficacy of New Dosage Schedule for Dietressa Drug in Treatment of Obese Patients
To assess safety of Dietressa in the dose of 6 tablets daily within 24 weeks in treatment of obese patients (BMI 35,0-39,9 kg/m2).
- Trial name
- NCT01570829
- Testing
- Dietressa
- Where
- 17 sites in Russia
- Volunteers
- 331 people
- Sponsor
- Materia Medica Holding
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