CompletedNCT04988646Updated Feb 9, 2023Results posted

Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject

An interventional study of Acyclovir 200 MG and Acyclovir 400 MG in Drug Use, sponsored by PT. Kimia Farma (Persero) Tbk. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by PT. Kimia Farma (Persero) Tbk · Not applicable, Interventional, and Basic science

From the registry’s dates

Registered 1 year 4 months after the study started (first participant enrolled Feb 2020, registered Jul 2021).

Phase: Not applicable
Study type: Interventional
Enrollment: 56
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study summary

The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT. Kimia Farma (Persero) Tbk) to its innovator product, Zovirax® tablet (Glaxo Wellcome S.A., Aranda, Spain)

Read the detailed description

Twenty-eight healty subjects were given a single dose of acyclovir tablet or Zovirax® in dosage form 200 mg and 400mg with 240 mL of water. Then the blood samples for acyclovir was drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Conditions studied

Drug Use

Keywords

bioequivalence
pharmacokinetics
Indonesian healthy subject
Acyclovir

In context

Lead sponsor

PT. Kimia Farma (Persero) Tbk is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

body weight within normal range (body mass index between 18 and 25 kg/m2)
had normal blood pressure (systolic was ranged between 90 to 120 mmHg and diastolic was ranged between 60 to 80 mmHg)
had normal electrocardiogram
absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening

Exclusion criteria

Exclusion Criteria:

pregnant women
nursing mothers
women of childbearing potential without adequate contraception
had a history of contraindication or hypersensitivity to aciclovir, or other antiviral or other ingredients in the study products or a history of serious allergic reaction to any drug,
a significant allergic disease, or allergic reaction; presence of medical condition which might significantly influence the pharmacokinetics of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease
presence of any coagulation disorder or clinically significant hematology abnormalities; using any medication (prescription or non-prescription drug, food supplement, herbal medicine)
particularly the medication known to affect the pharmacokinetics of the study drug
who had participated in any clinical study within 3 months prior to the study (\< 90 days)
subjects who had donated or lost 300 ml (or more) of blood within 3 months prior to the study
who were positive to HIV, HBsAg, and HCV tests
who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits
poor venous access; and who smoked more than 10 cigarettes a day
had a history of drug or alcohol abuse within 12 months prior to screening for this study and who were unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access

Study design

Phase: Not applicable
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 56 participants (actual)

Study arms

Experimental
Acyclovir Tablet
Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
Drug: Acyclovir 200 MG · Drug: Acyclovir 400 MG
Active comparator
Zovirax® Tablet
Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water
Drug: Zovirax 200 MG Tablet · Drug: Zovirax 400 MG Tablet

Interventions

DrugAcyclovir 200 MG
Administered with 240 mL of water
DrugAcyclovir 400 MG
Administered with 240 mL of water
DrugZovirax 200 MG Tablet
Administered with 240 mL of water
DrugZovirax 400 MG Tablet
Administered with 240 mL of water

What researchers measure

Primary outcomes

Pharmacokinetics Parameter
Maximum plasma concentration (Cmax)
Time frame: 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
Pharmacokinetics Parameter
Area Under Curve from 0 to 24 hours (AUCt)
Time frame: 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

Secondary outcomes

Geometric Mean Ratio
The ratio between maximum concentration of test drug and reference drug after drug administration
Time frame: 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
Geometric Mean Ratio
The ratio between area under curve from 0 to 24 hours of test drug and reference drug
Time frame: 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 Feb 8, 2023

Participant flow

1st Intervention

Participant flow — 1st Intervention
Milestone	Test Drug First, Then Reference Drug for Dose 200 mg	Reference Drug First, Then Test Drug for Dose 200 mg	Test Drug First, Then Reference Drug for Dose 400 mg	Reference Drug First, Then Test Drug for Dose 400 mg
Started	14	14	14	14
Completed	14	14	14	14
Not completed	0	0	0	0

Washout >= One Week

Participant flow — Washout >= One Week
Milestone	Test Drug First, Then Reference Drug for Dose 200 mg	Reference Drug First, Then Test Drug for Dose 200 mg	Test Drug First, Then Reference Drug for Dose 400 mg	Reference Drug First, Then Test Drug for Dose 400 mg
Started	14	14	14	14
Completed	14	14	14	14
Not completed	0	0	0	0

2nd Intervention

Participant flow — 2nd Intervention
Milestone	Test Drug First, Then Reference Drug for Dose 200 mg	Reference Drug First, Then Test Drug for Dose 200 mg	Test Drug First, Then Reference Drug for Dose 400 mg	Reference Drug First, Then Test Drug for Dose 400 mg
Started	14	14	14	14
Completed	13	13	14	14
Not completed	1	1	0	0

Outcome measures

PrimaryPharmacokinetics Parameter

Maximum plasma concentration (Cmax)

Time frame:: 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
Reported as:: Mean · ng/mL

Pharmacokinetics Parameter
ng/mL	Acyclovir 200 mg Tablet	Zovirax® 200 mg Tablet	Acyclovir 400 mg Tablet	Zovirax® 400 mg Tablet
Pharmacokinetics Parameter	613.21 ± 244.06	675.58 ± 258.18	807.13 ± 278.85	882.89 ± 351.97

PrimaryPharmacokinetics Parameter

Area Under Curve from 0 to 24 hours (AUCt)

Time frame:: 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
Reported as:: Mean · ng*h/mL

Pharmacokinetics Parameter
ng*h/mL	Acyclovir 200 mg Tablet	Zovirax® 200 mg Tablet	Acyclovir 400 mg Tablet	Zovirax® 400 mg Tablet
Pharmacokinetics Parameter	3609.80 ± 1425.19	3865.20 ± 1339.05	4583.29 ± 1518.93	5088.28 ± 1758.74

SecondaryGeometric Mean Ratio

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

Time frame:: 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
Reported as:: Geometric mean · percentage

Geometric Mean Ratio
percentage	Acyclovir 200 mg Tablet	Zovirax® 200 mg Tablet	Acyclovir 400 mg Tablet	Zovirax® 400 mg Tablet
Geometric Mean Ratio	90.65 (82.69 to 99.37)	90.65 (82.69 to 99.37)	93.63 (84.85 to 103.33)	93.63 (84.85 to 103.33)

SecondaryGeometric Mean Ratio

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

Time frame:: 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
Reported as:: Geometric mean · percentage

Geometric Mean Ratio
percentage	Acyclovir 200 mg Tablet	Zovirax® 200 mg Tablet	Acyclovir 400 mg Tablet	Zovirax® 400 mg Tablet
Geometric Mean Ratio	92.74 (86.04 to 99.96)	92.74 (86.04 to 99.96)	90.10 (80.80 to 100.48)	90.10 (80.80 to 100.48)

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Acyclovir 200 mg Tablet	0/28 (0%)	0/28 (0%)	1/26 (3.8%)
Zovirax® 200 mg Tablet	0/28 (0%)	0/28 (0%)	1/26 (3.8%)
Acyclovir 400 mg Tablet	0/28 (0%)	0/28 (0%)	1/28 (3.6%)
Zovirax® 400 mg Tablet	0/28 (0%)	0/28 (0%)	1/28 (3.6%)

Most frequent other events

Most frequent other events
Event	Acyclovir 200 mg Tablet	Zovirax® 200 mg Tablet	Acyclovir 400 mg Tablet	Zovirax® 400 mg Tablet
Headache, DizzinesNervous system disorders	1/26	1/26	1/28	1/28

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Total Number of Participants for Dose 200 mg	Total Number of Participants for Dose 400 mg	Total
<=18 years	0	0	0
Between 18 and 65 years	28	28	56
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Total Number of Participants for Dose 200 mg	Total Number of Participants for Dose 400 mg	Total
Female	10	7	17
Male	18	21	39

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Total Number of Participants for Dose 200 mg	Total Number of Participants for Dose 400 mg	Total
Count of participants	—	—	0

Study locations

1 site

PT Pharma Metric Labs
Jakarta Pusat, DKI Jakarta 10520, Indonesia

References and documents

Publications

Stahl JP, Mailles A. Herpes simplex virus encephalitis update. Curr Opin Infect Dis. 2019 Jun;32(3):239-243. doi: 10.1097/QCO.0000000000000554. PubMed 30921087 ↗
Ahronowitz I, Fox LP. Herpes zoster in hospitalized adults: Practice gaps, new evidence, and remaining questions. J Am Acad Dermatol. 2018 Jan;78(1):223-230.e3. doi: 10.1016/j.jaad.2017.07.054. Epub 2017 Nov 14. PubMed 29146146 ↗
Kukhanova MK, Korovina AN, Kochetkov SN. Human herpes simplex virus: life cycle and development of inhibitors. Biochemistry (Mosc). 2014 Dec;79(13):1635-52. doi: 10.1134/S0006297914130124. PubMed 25749169 ↗
Vaithianathan S, Haidar SH, Zhang X, Jiang W, Avon C, Dowling TC, Shao C, Kane M, Hoag SW, Flasar MH, Ting TY, Polli JE. Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir. J Pharm Sci. 2016 Feb;105(2):996-1005. doi: 10.1002/jps.24643. Epub 2016 Jan 12. PubMed 26375604 ↗
de Miranda P, Blum MR. Pharmacokinetics of acyclovir after intravenous and oral administration. J Antimicrob Chemother. 1983 Sep;12 Suppl B:29-37. doi: 10.1093/jac/12.suppl_b.29. PubMed 6355048 ↗
O'Brien JJ, Campoli-Richards DM. Acyclovir. An updated review of its antiviral activity, pharmacokinetic properties and therapeutic efficacy. Drugs. 1989 Mar;37(3):233-309. doi: 10.2165/00003495-198937030-00002. PubMed 2653790 ↗
Fletcher C, Bean B. Evaluation of oral acyclovir therapy. Drug Intell Clin Pharm. 1985 Jul-Aug;19(7-8):518-24. doi: 10.1177/106002808501900703. PubMed 2992899 ↗
Al-Yamani MJ, Al-Khamis KI, El-Sayed YM, Bawazir SA, Al-Rashood KA, Gouda MW. Comparative bioavailability of two tablet formulations of acyclovir in healthy volunteers. Int J Clin Pharmacol Ther. 1998 Apr;36(4):222-6. PubMed 9587049 ↗
Amini H, Javan M, Gazerani P, Ghaffari A, Ahmadiani A. Lack of bioequivalence between two aciclovir tablets in healthy subjects. Clin Drug Investig. 2008;28(1):47-53. doi: 10.2165/00044011-200828010-00006. PubMed 18081360 ↗
Weller S, Blum MR, Doucette M, Burnette T, Cederberg DM, de Miranda P, Smiley ML. Pharmacokinetics of the acyclovir pro-drug valaciclovir after escalating single- and multiple-dose administration to normal volunteers. Clin Pharmacol Ther. 1993 Dec;54(6):595-605. doi: 10.1038/clpt.1993.196. PubMed 8275615 ↗
Galgatte UC, Jamdade VR, Aute PP, Chaudhari PD. Study on requirements of bioequivalence for registration of pharmaceutical products in USA, Europe and Canada. Saudi Pharm J. 2014 Nov;22(5):391-402. doi: 10.1016/j.jsps.2013.05.001. Epub 2013 May 31. PubMed 25473327 ↗
Corrao G, Soranna D, La Vecchia C, Catapano A, Agabiti-Rosei E, Gensini G, Merlino L, Mancia G. Medication persistence and the use of generic and brand-name blood pressure-lowering agents. J Hypertens. 2014 May;32(5):1146-53; discussion 1153. doi: 10.1097/HJH.0000000000000130. Erratum In: J Hypertens. 2015 Jul;33(7):1495. J Hypertens. 2015 Oct;33(10):2181. PubMed 24569417 ↗
Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, Shrank WH. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008 Dec 3;300(21):2514-26. doi: 10.1001/jama.2008.758. PubMed 19050195 ↗

Study documents

Protocol and statistical analysis plan · Dec 13, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04988646
Lead sponsor: PT. Kimia Farma (Persero) Tbk
Collaborators: PT Pharma Metric Labs
Responsible party: Sponsor
First posted: Aug 3, 2021
Start date: Feb 21, 2020
Primary completion: Apr 20, 2020
Completion: Apr 28, 2020
Results posted: Feb 8, 2023
Last update: Feb 9, 2023

Study contacts

Metta Sinta Sari Wiria

principal investigator · PT Pharma Metric Labs

I Gusti Putu Bagus Diana Virgo

study director · PT Pharma Metric Labs

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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