Trial Outcomes & Findings for Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject (NCT NCT04988646)

Results Overview

Maximum plasma concentration (Cmax)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

56 participants

Primary outcome timeframe

before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

Results posted on

2023-02-09

Participant Flow

The study was conducted with two types of drug doses, which were dose of 200 mg and 400 mg. Of each dose performed on 28 subjects

Participant milestones

Participant milestones
Measure	Test Drug First, Then Reference Drug for Dose 200 mg Participants received New (test) Acyclovir Tablet 200 mg with 240 mL of water as a single oral dose in the first intervention period, and marketed (reference) Zovirax® 200 mg Tablet with 240 mL of water as a single oral dose in the second intervention period (after washout period).	Reference Drug First, Then Test Drug for Dose 200 mg Participants received marketed (reference) Zovirax® 200 mg Tablet with 240 mL of water as a single oral dose in the first intervention period, and new (test) Acyclovir 200 mg Tablet with 240 mL of water as a single oral dose in the second intervention period (after washout period).	Test Drug First, Then Reference Drug for Dose 400 mg Participants received New (test) Acyclovir Tablet 400 mg with 240 mL of water as a single oral dose in the first intervention period, and marketed (reference) Zovirax® 2x200 mg Tablet with 240 mL of water as a single oral dose in the second intervention period (after washout period).	Reference Drug First, Then Test Drug for Dose 400 mg Participants received marketed (reference) Zovirax® 2x200 mg Tablet with 240 mL of water as a single oral dose in the first intervention period, and new (test) Acyclovir 400 mg Tablet with 240 mL of water as a single oral dose in the second intervention period (after washout period).
1st Intervention STARTED	14	14	14	14
1st Intervention COMPLETED	14	14	14	14
1st Intervention NOT COMPLETED	0	0	0	0
Washout >= One Week STARTED	14	14	14	14
Washout >= One Week COMPLETED	14	14	14	14
Washout >= One Week NOT COMPLETED	0	0	0	0
2nd Intervention STARTED	14	14	14	14
2nd Intervention COMPLETED	13	13	14	14
2nd Intervention NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Number of Participants for Dose 200 mg n=28 Participants All participants received Acyclovir Tablet 200 mg with 240 mL of water (new and marketed)	Total Number of Participants for Dose 400 mg n=28 Participants All participants received Acyclovir Tablet 400 mg with 240 mL of water (new and marketed)	Total n=56 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=56 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=28 Participants	28 Participants n=28 Participants	56 Participants n=56 Participants
Age, Categorical >=65 years	0 Participants n=28 Participants	0 Participants n=28 Participants	0 Participants n=56 Participants
Sex: Female, Male Female	10 Participants n=28 Participants	7 Participants n=28 Participants	17 Participants n=56 Participants
Sex: Female, Male Male	18 Participants n=28 Participants	21 Participants n=28 Participants	39 Participants n=56 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

Maximum plasma concentration (Cmax)

Outcome measures

Outcome measures
Measure	Acyclovir 200 mg Tablet n=26 Participants Participants received Acyclovir Tablet 200 mg with 240 mL of water	Zovirax® 200 mg Tablet n=26 Participants Participants received Zovirax® Tablet 200 mg with 240 mL of water	Acyclovir 400 mg Tablet n=28 Participants Participants received Acyclovir Tablet 400 mg with 240 mL of water	Zovirax® 400 mg Tablet n=28 Participants Participants received Zovirax® Tablet 2x200 mg with 240 mL of water
Pharmacokinetics Parameter	613.21 ng/mL Standard Deviation 244.06	675.58 ng/mL Standard Deviation 258.18	807.13 ng/mL Standard Deviation 278.85	882.89 ng/mL Standard Deviation 351.97

PRIMARY outcome

Timeframe: Predose at (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours post dose

Area Under Curve from 0 to 24 hours (AUCt)

Outcome measures

Outcome measures
Measure	Acyclovir 200 mg Tablet n=26 Participants Participants received Acyclovir Tablet 200 mg with 240 mL of water	Zovirax® 200 mg Tablet n=26 Participants Participants received Zovirax® Tablet 200 mg with 240 mL of water	Acyclovir 400 mg Tablet n=28 Participants Participants received Acyclovir Tablet 400 mg with 240 mL of water	Zovirax® 400 mg Tablet n=28 Participants Participants received Zovirax® Tablet 2x200 mg with 240 mL of water
Pharmacokinetics Parameter	3609.80 ng*h/mL Standard Deviation 1425.19	3865.20 ng*h/mL Standard Deviation 1339.05	4583.29 ng*h/mL Standard Deviation 1518.93	5088.28 ng*h/mL Standard Deviation 1758.74

SECONDARY outcome

Timeframe: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

The ratio between maximum concentration of test drug and reference drug after drug administration

Outcome measures

Outcome measures
Measure	Acyclovir 200 mg Tablet n=26 Participants Participants received Acyclovir Tablet 200 mg with 240 mL of water	Zovirax® 200 mg Tablet n=26 Participants Participants received Zovirax® Tablet 200 mg with 240 mL of water	Acyclovir 400 mg Tablet n=28 Participants Participants received Acyclovir Tablet 400 mg with 240 mL of water	Zovirax® 400 mg Tablet n=28 Participants Participants received Zovirax® Tablet 2x200 mg with 240 mL of water
Geometric Mean Ratio	90.65 percentage Interval 82.69 to 99.37	90.65 percentage Interval 82.69 to 99.37	93.63 percentage Interval 84.85 to 103.33	93.63 percentage Interval 84.85 to 103.33

SECONDARY outcome

Timeframe: before dosing (0 h) and at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing

The ratio between area under curve from 0 to 24 hours of test drug and reference drug

Outcome measures

Outcome measures
Measure	Acyclovir 200 mg Tablet n=26 Participants Participants received Acyclovir Tablet 200 mg with 240 mL of water	Zovirax® 200 mg Tablet n=26 Participants Participants received Zovirax® Tablet 200 mg with 240 mL of water	Acyclovir 400 mg Tablet n=28 Participants Participants received Acyclovir Tablet 400 mg with 240 mL of water	Zovirax® 400 mg Tablet n=28 Participants Participants received Zovirax® Tablet 2x200 mg with 240 mL of water
Geometric Mean Ratio	92.74 percentage Interval 86.04 to 99.96	92.74 percentage Interval 86.04 to 99.96	90.10 percentage Interval 80.8 to 100.48	90.10 percentage Interval 80.8 to 100.48

Adverse Events

Acyclovir 200 mg Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Zovirax® 200 mg Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Acyclovir 400 mg Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Zovirax® 400 mg Tablet

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Acyclovir 200 mg Tablet n=26 participants at risk；n=28 participants at risk Participants received Acyclovir Tablet 200 mg with 240 mL of water	Zovirax® 200 mg Tablet n=26 participants at risk；n=28 participants at risk Participants received Zovirax® Tablet 200 mg with 240 mL of water	Acyclovir 400 mg Tablet n=28 participants at risk Participants received Acyclovir Tablet 400 mg with 240 mL of water	Zovirax® 400 mg Tablet n=28 participants at risk Participants received Zovirax® Tablet 2x200 mg with 240 mL of water
Nervous system disorders Headache, Dizzines	3.8% 1/26 • Number of events 26 • before dosing (0 h) at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing \[Not Specified\]	3.8% 1/26 • Number of events 26 • before dosing (0 h) at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing \[Not Specified\]	3.6% 1/28 • Number of events 28 • before dosing (0 h) at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing \[Not Specified\]	3.6% 1/28 • Number of events 28 • before dosing (0 h) at 15, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16 and 24 hours after dosing \[Not Specified\]

Additional Information

Pharma Metric Labs

Pharma Metric Labs, Indonesia

Phone: +62 21 4265310

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place