Drug UseNCT04988646

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

A study testing Acyclovir 200 MG, Acyclovir 400 MG and Zovirax 200 MG Tablet in people with Drug Use, run by PT. Kimia Farma (Persero) Tbk at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Drug Use
What is being tested?: Acyclovir 200 MG, Acyclovir 400 MG and Zovirax 200 MG Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteIndonesia
Study dates: 21 Feb 2020to 28 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

PT Pharma Metric Labs
Jakarta Pusat, DKI Jakarta, 10520

Other trials in Indonesia

About this study

Official title: Pharmacokinetic Properties of Acyclovir

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: Drug Use
Being tested: Acyclovir 200 MG, Acyclovir 400 MG, Zovirax 200 MG Tablet, Zovirax 400 MG Tablet
Keywords: bioequivalence, pharmacokinetics, Indonesian healthy subject, Acyclovir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acyclovir 200 MGDrug
Administered with 240 mL of water
Acyclovir 400 MGDrug
Administered with 240 mL of water
Zovirax 200 MG TabletDrug
Administered with 240 mL of water
Zovirax 400 MG TabletDrug
Administered with 240 mL of water

Study groups in NCT04988646
Study group	Role	What they receive
Acyclovir Tablet	Experimental	Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water Receives: Drug: Acyclovir 200 MG; Drug: Acyclovir 400 MG
Zovirax® Tablet	Active comparator	Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water Receives: Drug: Zovirax 200 MG Tablet; Drug: Zovirax 400 MG Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics Parameter
Maximum plasma concentration (Cmax)
Measured: 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)
Measured: 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 (2)

Geometric Mean Ratio
The ratio between maximum concentration of test drug and reference drug after drug administration
Measured: 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
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Feb 202028 Apr 2020

First posted3 Aug 2021
Study start21 Feb 2020
Primary completion20 Apr 2020
Study completion28 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Drug UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Randomized, single blind, single dose, 2-periods, cross-over design study with one week washout period between each treatment in 28 healthy subjects under fasting condition
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04988646
Sponsor's protocol ID: 515/STD/PML/2019
Status last verified: Feb 2023
First submitted: 6 Jul 2021
Last updated: 9 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

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.
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetic Properties of Acyclovir
ClinicalTrials.gov ID: NCT04988646
Acronym / sponsor ID: 515/STD/PML/2019
Conditions: Drug Use
Keywords: bioequivalence, pharmacokinetics, Indonesian healthy subject, Acyclovir
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: PT. Kimia Farma (Persero) TbkIndustry (pharma, biotech, devices)
Collaborators: PT Pharma Metric Labs
Study start: 21 Feb 2020 (actual)
Primary completion: 20 Apr 2020 (actual)
Study completion: 28 Apr 2020 (actual)
First posted: 3 Aug 2021 (actual)
Results: Posted 8 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Randomized, single blind, single dose, 2-periods, cross-over design study with one week washout period between each treatment in 28 healthy subjects under fasting condition

Arm	Type	Receives
Acyclovir Tablet	Experimental	Drug: Acyclovir 200 MG, Drug: Acyclovir 400 MGParticipants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water
Zovirax® Tablet	Active comparator	Drug: Zovirax 200 MG Tablet, Drug: Zovirax 400 MG TabletParticipants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acyclovir 200 MGAdministered with 240 mL of water	Drug	Acyclovir Tablet
Acyclovir 400 MGAdministered with 240 mL of water	Drug	Acyclovir Tablet
Zovirax 200 MG TabletAdministered with 240 mL of water	Drug	Zovirax® Tablet
Zovirax 400 MG TabletAdministered with 240 mL of water	Drug	Zovirax® Tablet

Primary outcome

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

2 secondary outcomes

Geometric Mean Ratio
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
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 and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Drug First, Then Reference Drug for Dose 200 mg	14	14
Reference Drug First, Then Test Drug for Dose 200 mg	14	14
Test Drug First, Then Reference Drug for Dose 400 mg	14	14
Reference Drug First, Then Test Drug for Dose 400 mg	14	14

Primary outcome: Pharmacokinetics Parameter

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. Mean (Standard Deviation). Unit: ng/mL

Measure	Acyclovir 200 mg Tablet n = 26	Zovirax® 200 mg Tablet n = 26	Acyclovir 400 mg Tablet n = 28	Zovirax® 400 mg Tablet n = 28
Value	613.21 (244.06)	675.58 (258.18)	807.13 (278.85)	882.89 (351.97)

Primary outcome: Pharmacokinetics Parameter

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. Mean (Standard Deviation). Unit: ng*h/mL

Measure	Acyclovir 200 mg Tablet n = 26	Zovirax® 200 mg Tablet n = 26	Acyclovir 400 mg Tablet n = 28	Zovirax® 400 mg Tablet n = 28
Value	3609.80 (1425.19)	3865.20 (1339.05)	4583.29 (1518.93)	5088.28 (1758.74)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acyclovir 200 mg Tablet	0 of 28 (0%)	1 of 26 (3.8%)	0 of 28
Zovirax® 200 mg Tablet	0 of 28 (0%)	1 of 26 (3.8%)	0 of 28
Acyclovir 400 mg Tablet	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28
Zovirax® 400 mg Tablet	0 of 28 (0%)	1 of 28 (3.6%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 30921087Stahl JP, Mailles A. Herpes simplex virus encephalitis update. Curr Opin Infect Dis. 2019 Jun;32(3):239-243. doi: 10.1097/QCO.0000000000000554.
Results publication: PubMed 29146146Ahronowitz 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.
Results publication: PubMed 25749169Kukhanova 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.
Results publication: PubMed 26375604Vaithianathan 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.
Results publication: PubMed 6355048de 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.
Results publication: PubMed 2653790O'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.
Results publication: PubMed 2992899Fletcher C, Bean B. Evaluation of oral acyclovir therapy. Drug Intell Clin Pharm. 1985 Jul-Aug;19(7-8):518-24. doi: 10.1177/106002808501900703.
Results publication: PubMed 9587049Al-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.
Results publication: PubMed 18081360Amini 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.
Results publication: PubMed 8275615Weller 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.
Results publication: PubMed 25473327Galgatte 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.
Results publication: PubMed 24569417Corrao 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Metta Sinta Sari Wiria principal investigator

PT Pharma Metric Labs

I Gusti Putu Bagus Diana Virgo study director

PT Pharma Metric Labs

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acyclovir 200 MG, Acyclovir 400 MG and Zovirax 200 MG Tablet in people with Drug Use, run by PT. Kimia Farma (Persero) Tbk at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics Parameter (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04988646, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.