Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the interaction between two investigational products by comparing and analyzing pharmacokinetic interactions and safety in steady state after multiple oral administration of ATB-1011 or ATB-1012 alone or in combination in healthy adult volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Active Comparator | ATB-1011: 1tab/d for 5days , ATB-1011+ATB-1012: each 1tab/d for 5days |
|
| Arm B | Active Comparator | ATB-1012: 1tab/d for 5days / ATB-1011+ATB-1012: each 1tab/d for 5days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan | Drug | First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| ATB-1011 AUCÏ„,ss | the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties. | 5days, 10days |
| ATB-1012 AUCÏ„,ss, | the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties. | 5days, 10days |
| ATB-1011 Cmax,ss | the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties. | 5days, 10days |
| ATB-1012 Cmax,ss | the primary endpoints, are converted into natural logarithms, and a point estimate of the difference between the mean values of single and co-administration and 90% confidence intervals thereof is evaluated to evaluate the pharmacokinetic properties. | 5days, 10days |
| Measure | Description | Time Frame |
|---|---|---|
| ATB-1011 Tmax,ss | Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group. | 5days, 10days |
| ATB-1011 Cmin,ss |
Not provided
Inclusion Criteria:
Exclusion Criteria:
- 1) Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system.
2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| KyungWan Nam, Pharm. D. | Autotelic.bio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | Gwanak-gu | 08779 | South Korea |
Not provided
| ID | Term |
|---|---|
| C437965 | olmesartan |
| C529054 | dapagliflozin |
Not provided
Not provided
Not provided
2 Intervention group, open, single-sequence, multiple oral administration crossover design
Not provided
Not provided
Not provided
Not provided
|
| Dapagliflozin | Drug | First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration |
|
|
Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group.
| 5days, 10days |
| ATB-1012 Tmax,ss | Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group. | 5days, 10days |
| ATB-1012 Cmin,ss | Pharmacokinetic parameters are calculated using a noncompartmental method and descriptive statistics of pharmacokinetic endpoints are presented for each investigational product administration group. | 5days, 10days |