A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
Phase 1
Completed
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Drug: BR2008-1 (R)Drug: BR2008 (T)
- Registration Number
- NCT05068193
- Lead Sponsor
- Boryung Pharmaceutical Co., Ltd
- Brief Summary
A clinical trial to compare the pharmacokinetics and bioequivalence of BR2008 with BR2008-1 in healthy volunteers
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 BR2008-1 (R) The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II. \*Sequence 1 \[Period I\] Administration of BR2008-1 (single dose) - Wash out for 2 weeks \[Period II\] Administration of BR2008 (single dose) Sequence 1 BR2008 (T) The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II. \*Sequence 1 \[Period I\] Administration of BR2008-1 (single dose) - Wash out for 2 weeks \[Period II\] Administration of BR2008 (single dose) Sequence 2 BR2008-1 (R) The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II. \*Sequence 2 \[Period I\] Administration of BR2008 (single dose) * Wash out for 2 weeks \[Period II\] Administration of BR2008-1 (single dose) Sequence 2 BR2008 (T) The investigational products will be administered according to the treatment groups(BR2008, BR2008-1) assigned to each sequence group in Period I and Period II. \*Sequence 2 \[Period I\] Administration of BR2008 (single dose) * Wash out for 2 weeks \[Period II\] Administration of BR2008-1 (single dose)
- Primary Outcome Measures
Name Time Method AUCt 0-120 hours after administration Area under the plasma drug concentration-time curve from time 0 to time t of BR2008 and BR2008-1
Cmax 0-120 hours after administration Maximum concentration of drug in plasma of BR2008 and BR2008-1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bestian Hospital
🇰🇷Osong, Korea, Republic of
Bestian Hospital🇰🇷Osong, Korea, Republic of