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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...
Bisoprolol-Amlodipine is a combination of two small-molecule drugs being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioequivalence trial in Chinese participants. The drug is not approved and remains investigational.
Bisoprolol-Amlodipine is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the combination product.
Bisoprolol-Amlodipine is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 bioequivalence trial has been completed.
Bisoprolol-Amlodipine has one completed clinical trial, NCT03226275, titled "Bioequivalence Trial of Concor AM® vs Bisoprolol and Amlodipine in Chinese Participants." This Phase 1 study enrolled 32 healthy volunteers in China and was controlled but not double-blind.
Bisoprolol-Amlodipine is being studied as a potential generic or alternative to Concor AM. The clinical trial NCT03226275 compares the combination product to Concor AM, which contains bisoprolol and amlodipine, to assess bioequivalence.