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Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects.
Clin Pharmacol Drug Dev. 2020 Jul; 9(5):573-581.CP

Abstract

Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallowing or administration with fluids has been developed. The bioequivalence and bioavailability of sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets (50 mg) in an open-label, randomized crossover study. Healthy Chinese male subjects (n = 36) were allocated to 1 of 6 sildenafil citrate treatment sequences under fasted conditions, and plasma samples for determination of sildenafil concentrations were collected predose through 14 hours postdose. Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUClast , Cmax , and AUCinf (ratio, 101.41%; 90%CI, 95.49%-107.70%; ratio, 93.55%; 90%CI, 84.15%-104.00%; and ratio, 101.03%; 90%CI, 94.80%-107.66%; respectively) were wholly contained within the bioequivalence acceptance range of 80% to 125%, indicating bioequivalence criteria were met. Relative bioavailability of sildenafil citrate ODT administered with water to the sildenafil citrate tablet (50 mg) administered with water was 97.10%, 91.43%, and 97.09% with respect to sildenafil AUClast , Cmax , and AUCinf , respectively (90%CI, 91.43%-03.12%, 82.25%-101.65%, and 90.90%-103.71%, respectively). Both sildenafil citrate formulations were generally well tolerated in healthy Chinese men. Sildenafil citrate ODT administered without or with water was bioequivalent to or met bioequivalence criteria compared with conventional sildenafil citrate tablets administered with water under fasted conditions in healthy Chinese men, thus offering a convenient alternative method of oral administration.

Authors+Show Affiliations

Peking University First Hospital, Institute of Clinical Pharmacology, Beijing, China.Pfizer Inc, Shanghai, China.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Shanghai, China.Pfizer Inc, Beijing, China.ExecuPharm, King of Prussia, Pennsylvania, USA.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Groton, Connecticut, USA.Pfizer Inc, Groton, Connecticut, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32463593

Citation

Lv, Yuan, et al. "Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects." Clinical Pharmacology in Drug Development, vol. 9, no. 5, 2020, pp. 573-581.
Lv Y, Luo BY, LaBadie RR, et al. Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects. Clin Pharmacol Drug Dev. 2020;9(5):573-581.
Lv, Y., Luo, B. Y., LaBadie, R. R., Zhu, H., Feng, Y., Ernst, C., Crownover, P. H., Liang, Y., & Zhao, Q. (2020). Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects. Clinical Pharmacology in Drug Development, 9(5), 573-581. https://doi.org/10.1002/cpdd.806
Lv Y, et al. Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects. Clin Pharmacol Drug Dev. 2020;9(5):573-581. PubMed PMID: 32463593.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bioequivalence and Bioavailability of an Orodispersible Tablet of Sildenafil Citrate in Healthy Chinese Male Subjects. AU - Lv,Yuan, AU - Luo,Bin-Yu, AU - LaBadie,Robert R, AU - Zhu,Hua, AU - Feng,Yan, AU - Ernst,Cynthia, AU - Crownover,Penelope H, AU - Liang,Yali, AU - Zhao,Qinying, Y1 - 2020/05/28/ PY - 2019/02/13/received PY - 2020/03/24/accepted PY - 2020/5/29/pubmed PY - 2020/5/29/medline PY - 2020/5/29/entrez KW - bioavailability KW - bioequivalence KW - erectile dysfunction KW - orally disintegrating tablet KW - pharmacokinetics KW - sildenafil citrate SP - 573 EP - 581 JF - Clinical pharmacology in drug development JO - Clin Pharmacol Drug Dev VL - 9 IS - 5 N2 - Sildenafil citrate is approved to treat erectile dysfunction. An orally disintegrating tablet (ODT) of sildenafil citrate that does not require swallowing or administration with fluids has been developed. The bioequivalence and bioavailability of sildenafil citrate ODT (50 mg) without and with water were compared with conventional sildenafil citrate tablets (50 mg) in an open-label, randomized crossover study. Healthy Chinese male subjects (n = 36) were allocated to 1 of 6 sildenafil citrate treatment sequences under fasted conditions, and plasma samples for determination of sildenafil concentrations were collected predose through 14 hours postdose. Bioequivalence was demonstrated for sildenafil citrate ODT administered without water relative to the sildenafil citrate tablet administered with water; 90%CIs for the ratios of adjusted geometric means for sildenafil AUClast , Cmax , and AUCinf (ratio, 101.41%; 90%CI, 95.49%-107.70%; ratio, 93.55%; 90%CI, 84.15%-104.00%; and ratio, 101.03%; 90%CI, 94.80%-107.66%; respectively) were wholly contained within the bioequivalence acceptance range of 80% to 125%, indicating bioequivalence criteria were met. Relative bioavailability of sildenafil citrate ODT administered with water to the sildenafil citrate tablet (50 mg) administered with water was 97.10%, 91.43%, and 97.09% with respect to sildenafil AUClast , Cmax , and AUCinf , respectively (90%CI, 91.43%-03.12%, 82.25%-101.65%, and 90.90%-103.71%, respectively). Both sildenafil citrate formulations were generally well tolerated in healthy Chinese men. Sildenafil citrate ODT administered without or with water was bioequivalent to or met bioequivalence criteria compared with conventional sildenafil citrate tablets administered with water under fasted conditions in healthy Chinese men, thus offering a convenient alternative method of oral administration. SN - 2160-7648 UR - https://www.unboundmedicine.com/medline/citation/32463593/Bioequivalence_and_Bioavailability_of_an_Orodispersible_Tablet_of_Sildenafil_Citrate_in_Healthy_Chinese_Male_Subjects L2 - https://doi.org/10.1002/cpdd.806 DB - PRIME DP - Unbound Medicine ER -
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