Key result
Fangming amlodipine achieves bioequivalence to NORVASC in healthy volunteers.
Why the study?
The trial was conducted to evaluate the pharmacokinetics, safety, and bioequivalence of orally administered amlodipine from two sponsors in healthy volunteers under fasting and fed conditions.
Is a generic amlodipine formulation bioequivalent to the reference product in healthy volunteers?
RCT (n=48)
Open-label
randomized
Is a generic amlodipine formulation bioequivalent to the reference product in healthy volunteers?
Absolute Event Rate: 3.881% vs 4.042%
The generic amlodipine formulation from Fangming Pharmaceutical Group is bioequivalent to NORVASC under both fasting and fed conditions in healthy Chinese volunteers.
Supports generic substitution to improve amlodipine access; confirms bioequivalence standards in Chinese volunteers.
Background and Objective Amlodipine, a main series of L‐type calcium channel blockers (CCBs), exerts potent antihypertensive effects. The aim of this trial was to explore the pharmacokinetics (PK) and safety with bioequivalence of orally administered Amlodipine provided by two sponsors in healthy volunteers (HVs). Methods Two separate randomized, open‐label, single‐dose, crossover‐design studies were conducted: a fasting study (n = 24) and a fed study (n = 24). In each study, HVs were randomized to Fangming Pharmaceutical Group (Test, T) followed by NORVASC® (Reference, R), or vice versa. Each study subject received a 5‐mg Amlodipine tablet with a 15‐day washout. The plasma concentrations of Amlodipine were measured using a LC‐MS/MS method, and PK parameters were determined by noncompartmental model. Results Forty‐eight healthy volunteers were enrolled. And overall demographics were as follows: the fasting study: female (n = 16/24), age (18‐54 years), weight (47‐76 kg), and BMI (19.5‐26.0). The fed study: female (n = 16/24), age (20‐49 years), weight (45.5‐69 kg), and BMI (19.1‐25.0). All PK endpoints met the pre‐specific criteria for PK equivalence. In fasting subjects, the maximum plasma concentration (Cmax) was 3.881 ± 0.982 ng/mL at 6 hours (median) of sponsor T, and 4.042 ± 1.147 ng/mL at 6 hours (median) of sponsor R. In fed subjects, Cmax was 3.312 ± 0.789 ng/mL at 6 hours (median) of sponsor T, and 3.392 ± 0.902 ng/mL at 5 hours (median) of sponsor R. Both fasting and fed studies achieved a plausible bioequivalence. Conclusions Amlodipine is well tolerated and have a favorable safety profile. The observed adverse events were mild (the severity was assessed according to the Common Terminology Criteria for Adverse Events [version CTCAE4.03]) and all of them were recovered without severe sequences. And the bioequivalence is achieved under fasting and fed conditions, supporting the demonstration of biosimilarity.
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Wang et al. (2020) conducted an RCT in Healthy volunteers (n=48). Amlodipine (Fangming Pharmaceutical Group) vs. NORVASC was evaluated on Maximum plasma concentration (Cmax) in fasting subjects (ng/mL). Amlodipine from Fangming Pharmaceutical Group achieved bioequivalence to NORVASC in healthy volunteers, with a fasting Cmax of 3.881 ng/mL vs 4.042 ng/mL.
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