Phase I Study on Multiple Oral Dosing of CG100649
NCT01154790 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2016-01-28
Summary
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of 3 escalating loading and maintenance dose regimens of CG100649 administered orally for 7 total days in healthy volunteers.
Conditions
- Healthy
Interventions
- DRUG
-
CG100649
6 subjects: study drug 2 subjects: placebo
- DRUG
-
6 subjects: study drug 2 subjects: placebo
- DRUG
-
Naproxen
6 subjects: study drug 2 subjects: placebo
Sponsors & Collaborators
-
CrystalGenomics, Inc.
lead INDUSTRY
Principal Investigators
-
Seonggu Ro · CrystalGenomics, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2011-01-31
- Completion
- 2011-01-31
Countries
- South Korea
Study Locations
More Related Trials
-
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
NCT00674856 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
NCT00621881 ·Status: COMPLETED ·Phase: PHASE1
-
Naproxen Sodium Extended-Release Actual Use Study
NCT00751400 ·Status: COMPLETED ·Phase: PHASE3
-
Pilot Study of OXP005 to Assess Gastroduodenal Irritation
NCT02408978 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers
NCT04639804 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.
NCT00367211 ·Status: COMPLETED ·Phase: PHASE3
-
Changes in mRNA Expression Following Exposure to Naproxen
NCT01090596 ·Status: COMPLETED ·Phase: NA
-
Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian
NCT05181124 ·Status: COMPLETED ·Phase: PHASE1
-
Celebrex Low Dose ASA Study Examining the Incidence of Gastroduodenal Ulcers in a Healthy Population
NCT00137033 ·Status: COMPLETED ·Phase: PHASE4
-
Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
NCT00665743 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics Study Comparing Naproxen Sodium Extended Release and Naprelan
NCT00969449 ·Status: COMPLETED ·Phase: PHASE1
-
Study Evaluating the Bioavailability of Naproxen 375 mg in Two Formulations
NCT00692055 ·Status: COMPLETED ·Phase: PHASE1
-
A Multiple-Dose Pharmacokinetics Study of Two Gefapixant (AF-219/MK-7264) Formulations
NCT02492776 ·Status: COMPLETED ·Phase: PHASE1
-
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
NCT04139824 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Study PK Study With OXP005 and Naprosyn
NCT02351024 ·Status: COMPLETED ·Phase: PHASE1
-
Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study
NCT03167541 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male
NCT01404598 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fasting Condition
NCT01052129 ·Status: COMPLETED ·Phase: PHASE1
-
Naproxen Pharmacogenetic Study (Project 1, Aim 2)
NCT04449471 ·Status: UNKNOWN ·Phase: PHASE4
-
Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole
NCT05237297 ·Status: COMPLETED ·Phase: PHASE1
-
A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects
NCT03396250 ·Status: COMPLETED ·Phase: PHASE1
-
Naproxen Sodium ER Pharmacokinetic Study
NCT00818415 ·Status: COMPLETED ·Phase: PHASE1
-
Actual Use Trial of Naproxen Sodium
NCT01427803 ·Status: COMPLETED ·Phase: PHASE3
-
Oral Bioequivalence Study of PL 3100 and Naproxen in Healthy Adults
NCT00966641 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants
NCT06511973 ·Status: COMPLETED ·Phase: PHASE1