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| Name | Class |
|---|---|
| PT Pharma Metric Labs | INDUSTRY |
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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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acyclovir Tablet | Experimental | Participants received Acyclovir Tablet 200 mg or 400 mg with 240 mL of water |
|
| Zovirax® Tablet | Active Comparator | Participants received Zovirax® Tablet 200 mg or 2x200 mg with 240 mL of water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acyclovir 200 MG | Drug | Administered with 240 mL of water |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter | Maximum plasma concentration (Cmax) | 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) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Ratio | The ratio between maximum concentration of test drug and reference drug after drug administration | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Metta Sinta Sari Wiria | PT Pharma Metric Labs | Principal Investigator |
| I Gusti Putu Bagus Diana Virgo | PT Pharma Metric Labs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PT Pharma Metric Labs | Jakarta Pusat | DKI Jakarta | 10520 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30921087 | Result | Stahl JP, Mailles A. Herpes simplex virus encephalitis update. Curr Opin Infect Dis. 2019 Jun;32(3):239-243. doi: 10.1097/QCO.0000000000000554. | |
| 29146146 | Result | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1st Intervention |
| |||||||||||||
| Washout >= One Week |
| |||||||||||||
| 2nd Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Number of Participants for Dose 200 mg | All participants received Acyclovir Tablet 200 mg with 240 mL of water (new and marketed) |
| BG001 | Total Number of Participants for Dose 400 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics Parameter | Maximum plasma concentration (Cmax) | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
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]
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acyclovir 200 mg Tablet | Participants received Acyclovir Tablet 200 mg with 240 mL of water |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache, Dizzines | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pharma Metric Labs | Pharma Metric Labs, Indonesia | +62 21 4265310 | nabila.sutanto@pharmametriclabs.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 13, 2019 | Oct 6, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000212 | Acyclovir |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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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
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| Acyclovir 400 MG |
| Drug |
Administered with 240 mL of water |
|
| Zovirax 200 MG Tablet | Drug | Administered with 240 mL of water |
|
| Zovirax 400 MG Tablet | Drug | Administered with 240 mL of water |
|
The ratio between area under curve from 0 to 24 hours of test drug and reference drug |
| 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 |
| 25749169 | Result | 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. |
| 26375604 | Result | 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. |
| 6355048 | Result | 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. |
| 2653790 | Result | 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. |
| 2992899 | Result | 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. |
| 9587049 | Result | 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. |
| 18081360 | Result | 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. |
| 8275615 | Result | 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. |
| 25473327 | Result | 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. |
| 24569417 | Result | 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. |
| 19050195 | Result | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
All participants received Acyclovir Tablet 400 mg with 240 mL of water (new and marketed)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Participants received Acyclovir Tablet 400 mg with 240 mL of water
| OG003 | Zovirax® 400 mg Tablet | Participants received Zovirax® Tablet 2x200 mg with 240 mL of water |
|
|
| Primary | Pharmacokinetics Parameter | Area Under Curve from 0 to 24 hours (AUCt) | Posted | Mean | Standard Deviation | ng*h/mL | 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 | Geometric Mean Ratio | The ratio between maximum concentration of test drug and reference drug after drug administration | Posted | Geometric Mean | 90% Confidence Interval | percentage | 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 |
|
|
|
| Secondary | Geometric Mean Ratio | The ratio between area under curve from 0 to 24 hours of test drug and reference drug | Posted | Geometric Mean | 90% Confidence Interval | percentage | 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 |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 1 |
| 26 |
| EG001 | Zovirax® 200 mg Tablet | Participants received Zovirax® Tablet 200 mg with 240 mL of water | 0 | 28 | 0 | 28 | 1 | 26 |
| EG002 | Acyclovir 400 mg Tablet | Participants received Acyclovir Tablet 400 mg with 240 mL of water | 0 | 28 | 0 | 28 | 1 | 28 |
| EG003 | Zovirax® 400 mg Tablet | Participants received Zovirax® Tablet 2x200 mg with 240 mL of water | 0 | 28 | 0 | 28 | 1 | 28 |
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| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |