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Clinical Trial Report

Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies

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Pages 669-681 | Published online: 10 Apr 2017

Figures & data

Figure 1 Study design of (A) pharmacokinetic study and (B) safety study.

Notes: *PK sampling: 0 hour (pre-dose), 0.25, 0.5, 1, 2, 4, 8, and 12 hours. $PK sampling: 0 hour (trough–24 hours after 1st dose-trough). PK sampling: 0 hour (trough). ΦAll 3 subjects withdrew from the study with consent, and the withdrawal was not related to the treatment. #One subject was not included in the safety population because of randomization error and for not receiving the investigational product.
Abbreviations: IP, investigational product; PK, pharmacokinetics; TC, telephonic contact.
Figure 1 Study design of (A) pharmacokinetic study and (B) safety study.

Table 1 Baseline characteristics and subject demographics

Figure 2 Mean olopatadine 0.77% plasma concentration over time (A) and AUC0–12 (B) following single-dose (Day 1) and multiple-dose (Day 7) exposure.

Notes: #n=9 at 8- and 12-hour time points due to study consent withdrawal. Data for Day 7 AUC0–12 are from 19 subjects. AUC0–12, area under the plasma concentration–time curve from 0 to 12 hours.
Figure 2 Mean olopatadine 0.77% plasma concentration over time (A) and AUC0–12 (B) following single-dose (Day 1) and multiple-dose (Day 7) exposure.

Table 2 Pharmacokinetic parameters following single- and multiple-dose exposures of olopatadine 0.77% (pharmacokinetics population)

Table 3 Summary of TEAEs regardless of study drug relationship by treatment (safety population)

Table 4 Summary of TEAEs in the selected age subgroups occurring at an incidence of ≥1% by treatment

Table 5 Summary of safety parameters in the overall safety population and selected age subgroups at Week 6 or at the Early Exit visit by treatment

Table S1 Pharmacokinetic parameters following single- and multiple-dose exposures of olopatadine 0.77% in Japanese and non-Japanese subjects

Table S2 Overall summary of treatment-related AEs occurring at an incidence of ≥1% by treatment (safety population)

Table S3 Summary of TEAEs in selected age subgroups occurring at an incidence of ≥1% by treatment (safety population)

Table S4 Comparison of mean human plasma pharmacokinetic parameters following topical ocular and oral single- and multiple-dose exposures of olopatadine