H Plus Yangji Hospital
Seoul, Gwanak-gu, 08779, South Korea
Location status: Recruiting
Location contact
CONTACT
NCT Number: NCT07083388
This was an open-label, randomized, fasting, single-dose, 2-sequence, 2-period crossover study to evaluate the pharmacokinetics and safety between single oral administration of "BR3006" and co-administration of "BR3006A", "BR3006B," and "BR3006C" in healthy adult volunteers.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Phase 1
Seoul, Gwanak-gu, 08779, South Korea
Location status: Recruiting
CONTACT
A total of 52 healthy volunteers will be enrolled to evaluate the pharmacokinetics and safety profiles of the study drug (one combination tablet of dapagliflozin 10 mg/pioglitazone 30 mg/metformin HCl 1000 mg) and the comparator (co-administration of dapagliflozin 10 mg, pioglitazone 30 mg, and metformin HCl 1000 mg, one tablet each, respectively) while fasting.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orally administered once per day
Other names: BR3006
Orally administered once per day
Other names: BR3006A
Orally administered once per day
Other names: BR3006B
Orally administered once per day
Other names: BR3006C
Time frame: From Day 1, 0 hour (pre-dose) to Day 5 after dose administration
Maximum plasma concentration of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"
Time frame: From Day 1, 0 hour (pre-dose) to Day 5 after dose administration
Area under the drug concentration-time curve over the time interval of "BR3006" and "BR3006A," "BR3006B," and "BR3006C"
Contact information is provided by the study sponsor or research team.
Boryung Pharmaceutical Co., Ltd
Industry
An Open-label, Randomized, Fasting, Single-dose, 2-sequence, 2-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between Single Oral Administration of "BR3006" and Co-administration of "BR3006A", "BR3006B" and "BR3006C" in Healthy Adult 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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