Key result
Trial evaluates bioequivalence of two valsartan formulations with no results yet reported.
RCT
Open-label
Randomized-Sequence
No
Absence of results precludes bioequivalence conclusion; leaves open whether the formulations are interchangeable.
All study participants were recruited at the clinical research centre by GCP-certified investigators, and were deemed eligible to participate in this study.The inclusion criteria were male between the age of 21 to 55, within 20% of ideal body weight for height and build according to the Metropolitan Life Insurance Company Standard, or body mass index between 18.5 to 29.9, in good health and physical condition as determined by medical history and laboratory test.
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Wen Yao Mak Siew Siew Tan (2015) conducted an RCT in Healthy Volunteers. Valsartan vs. Valsartan (alternate formulation) was evaluated. An open-label, randomized crossover study was designed to evaluate the bioequivalence of two valsartan 160 mg formulations in healthy males, but no results are reported in the abstract.
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