At a glance
ClinicalIndex Comparison Record- ✓Chinese male and female volunteers
- ✓Body mass index 18 to <28 kg/m²
- ✓Systolic BP 100-139 mmHg and diastolic BP 65-90 mmHg (supine) at screening and predose
- ✓Clinical laboratory values within normal range or clinically insignificant if outside range
- ✕Significant hypersensitivity to bisoprolol, amlodipine, dihydropyridines, or related products
- ✕Severe hypersensitivity reactions (e.g., angioedema) to any drug
- ✕Pulse rate <60 or >100 bpm at screening
- ✕QTc prolongation >430 msec, severe sinus node dysfunction, or 2nd/3rd degree AV block
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Two-period Crossover Trial Examining Bioequivalence of Bisoprolol-Amlodipine 5 mg/5 mg Combination Tablets Versus Bisoprolol 5 mg Tablets and Amlodipine 5 mg Tablets Given Concomitantly in Healthy Subjects in Fasting and Fed State
In Brief
A Phase 1 clinical trial evaluating Bisoprolol-Amlodipine FDC, Bisoprolol, and 1 other intervention for Healthy. Completed, enrolled 32 participants across 1 site.
Detailed Summary
This is a Phase I, open-label, randomized, 2-period, 2-sequence, crossover study to demonstrate bioequivalence (BE) between the bisoprolol-amlodipine fixed-dose-combination (FDC) tablet (investigational product) and bisoprolol and amlodipine tablets administered concomitantly (comparators) given as a single oral dose in fasting and fed state.
Study Details
Timeline
Interventions
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.
Participants received 5 mg bisoprolol tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions.
Participants received 5 mg amlodipine tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions.