Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Bisoprolol-Amlodipine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Fasting: First Bisoprolol-Amlodipine FDC, Then Both Separately | EXPERIMENTAL | Participants received a single oral dose of 5 milligram(mg)/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 1 in treatment period 1 followed by a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 15 in treatment period 2 under fasting conditions. The two periods were separated by a washout period of 14 days. |
| Fasting: First Bisoprolol and Amlodipine Separately, Then FDC | EXPERIMENTAL | Participants received a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 1 in treatment period 1 followed by a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 15 in treatment period 2 under fasting conditions. The two periods were separated by a washout period of 14 days. |
| Fed: First Bisoprolol-Amlodipine FDC, Then Both Separately | EXPERIMENTAL | Participants received a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 1 in treatment period 1 followed by a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 15 in treatment period 2 under fed conditions. The two periods were separated by a washout period of 14 days. |
| Fed: First Bisoprolol and Amlodipine Separately, Then FDC | EXPERIMENTAL | Participants received a single oral dose of 5 mg bisoprolol and a single oral dose of 5 mg amlodipine given concomitantly on Day 1 in treatment period 1 followed by a single oral dose of 5 mg/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) on Day 15 in treatment period 2 under fed conditions. The two periods were separated by a washout period of 14 days. |
| Name | Type | Description |
|---|---|---|
| Bisoprolol-Amlodipine FDC | DRUG | Participants received a single oral dose of 5 milligram(mg)/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) either on Day 1 or Day 15 under fasting or fed conditions. |
| Bisoprolol | DRUG | Participants received 5 mg bisoprolol tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions. |
| Amlodipine | DRUG | Participants received 5 mg amlodipine tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions. |
Inclusion Criteria: * Availability for the entire trial period and willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer * Chinese male and female volunteer * Volunteer with a body mass index greater than or e...