Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT03775629
This is a randomized, open-label, multiple-dose, parallel, Phase 1 study to compare the pharmacokinetics and to evaluate Drug-Drug Interaction of "CG100650" in healthy volunteers.
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Notify Me19 year–50 year
All sexes
Interventional
Phase 1
Seoul, 03080, South Korea
This is a randomized, open label, multiple-dose, parallel study to compare PK and to evaluate Drug-Drug Interaction of CG100650 in healthy volunteers.
Total of 39 health volunteers will be randomized to receive either of Group A, B or C for 14 days (13 subjects each).
[Group A] Tramadol +Polmacoxib capsule [Group B] Polmacoxib capsule [Group C] Tramadol
Pharmacokinetic parameters will be evaluated as primary endpoint by changes from baseline;
Safety evaluation will be carried out by conducting vital sign, laboratory test, ECG, and collecting AE, CM by different Group.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Tramadol hydrochloride , Polmacoxib
Polmacoxib
Tramadol hydrochloride (HCl)
Other names: Tramadol
Time frame: up to 4 weeks
Time frame: up to 4 weeks
Time frame: up to 4 weeks
Time frame: up to 4 weeks
Time frame: up to 4 weeks
Time frame: up to 4 weeks
CrystalGenomics, Inc.
Industry
A Randomized, Open-label, Multiple-dose, Parallel Study to Compare the Pharmacokinetics and to Evaluate Drug-Drug Interaction of "CG100650" in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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