Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT03826485
  4. Details
NCT03826485 Clinical Trial

Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects

Healthy Clinical Trial

Official title:
A Randomized, Open-label, Single-dose, Crossover Study to Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup in Healthy Male Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03826485
Other study ID # PRIC
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2019
Est. completion date July 31, 2019

Study information
Verified date January 2019
Source SamA Pharmaceutical Co., Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is Safety, Pharmacokinetic Study of PRIC

Description:

1. To Compare Pharmacokinetics of PRIC and Pranlukast Dry Syrup

2. To evaluate the safety and tolerability of PRIC and Pranlukast Dry Syrup

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 48
Est. completion date July 31, 2019
Est. primary completion date April 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 19 Years to 40 Years
Eligibility Inclusion Criteria:

- 19 to 45 years old healthy male subject at the screening

- Subject who is able to provide written informed consent and decided on his own participation after understanding fully to hear a detailed explanation in the clinical study

Exclusion Criteria:

- Subject with hereditary diseases of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.

- Subjects with history of clinically significant allergy, cardiovascular, peripheral vascular, skin, mucocutaneous, ocular, ear, nose and throat (ENT), respiratory, musculoskeletal, infectious, gastrointestinal, liver, biliary, endocrine, renal, genitourinary, nervous, psychiatric, blood disorders, tumors, fractures or any other conditions

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PRIC
Pranlukast hydrate 50mg
• Pranlukast hydrate
Pranlukast hydrate 225mg/2.25g

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul Songpa-gu

Sponsors (1)
Lead Sponsor Collaborator
SamA Pharmaceutical Co., Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area Under the Curve (AUC) to last time point (t) Area under the PRIC/Pranlukast dry syrup concentration in blood-time curve from zero to the final 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
Primary Maximum concentration of drug (Cmax) The maximum PRIC/Pranlukast dry syrup concentration in blood sampling time t 0, 0.5, 0.75, 1, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 10 and 12hours postdose
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1