Trial Outcomes & Findings for Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions (NCT NCT04318535)
NCT ID: NCT04318535
Last Updated: 2020-12-28
Results Overview
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized Cmax (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for Cmax to assess bioequivalence.
COMPLETED
PHASE1
36 participants
Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each period
2020-12-28
Participant Flow
This was an open label, randomized,3-treatment,3-period, single dose, crossover study. Bioequivalence between test Griseofulvin tablets (500 milligram \[mg\]) versus reference Griseofulvin tablets 500 mg and dose proportionality between test Griseofulvin tablets (250 mg and 500 mg) were evaluated in healthy adult participants under fed conditions.
A total of 36 participants were enrolled and received study treatment. The study had 3 periods: Period 1 (Day -1 to Day 5), Period 2 (Day 7 to Day 12) and Period 3 (Day 17 to Day 22) with a washout of atleast 7 days (not more than 14 days) between two subsequent dosing days.
Participant milestones
| Measure |
Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R
Participants received a single oral dose of Griseofulvin 500 mg (Treatment 1 \[T1\]) in treatment period 1 (Day 1) followed by Griseofulvin 250 mg (T2) in treatment period 2 (Day 8) followed by Griseofulvin 500 mg (Reference \[R\]) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
|
Griseofulvin 250-T2/Griseofulvin 500-R/Griseofulvin 500-T1
Participants received a single oral dose of Griseofulvin 250 mg (T2) in treatment period 1 (Day 1) followed by Griseofulvin 500 mg (R) in treatment period 2 (Day 8) followed by Griseofulvin 500 mg (T1) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
|
Griseofulvin 500-R/Griseofulvin 500-T1/Griseofulvin 250-T2
Participants received a single oral dose of Griseofulvin 500 mg (R) in treatment period 1 (Day 1) followed by Griseofulvin 500 mg (T1) in treatment period 2 (Day 8) followed by Griseofulvin 250 mg (T2) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
|
|---|---|---|---|
|
Treatment Period 1 (Day -1 to Day 5)
STARTED
|
12
|
12
|
12
|
|
Treatment Period 1 (Day -1 to Day 5)
COMPLETED
|
12
|
12
|
12
|
|
Treatment Period 1 (Day -1 to Day 5)
NOT COMPLETED
|
0
|
0
|
0
|
|
Period1washout(Atleast 7 Days Post-dose)
STARTED
|
12
|
12
|
12
|
|
Period1washout(Atleast 7 Days Post-dose)
COMPLETED
|
12
|
12
|
12
|
|
Period1washout(Atleast 7 Days Post-dose)
NOT COMPLETED
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 7 to Day 12)
STARTED
|
12
|
12
|
12
|
|
Treatment Period 2 (Day 7 to Day 12)
COMPLETED
|
12
|
12
|
12
|
|
Treatment Period 2 (Day 7 to Day 12)
NOT COMPLETED
|
0
|
0
|
0
|
|
Period2washout(Atleast 7 Days Post-dose)
STARTED
|
12
|
12
|
12
|
|
Period2washout(Atleast 7 Days Post-dose)
COMPLETED
|
12
|
11
|
12
|
|
Period2washout(Atleast 7 Days Post-dose)
NOT COMPLETED
|
0
|
1
|
0
|
|
Treatment Period 3 (Day 17 to Day 22)
STARTED
|
12
|
11
|
12
|
|
Treatment Period 3 (Day 17 to Day 22)
COMPLETED
|
12
|
11
|
12
|
|
Treatment Period 3 (Day 17 to Day 22)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Griseofulvin 500-T1/Griseofulvin 250-T2/Griseofulvin 500-R
Participants received a single oral dose of Griseofulvin 500 mg (Treatment 1 \[T1\]) in treatment period 1 (Day 1) followed by Griseofulvin 250 mg (T2) in treatment period 2 (Day 8) followed by Griseofulvin 500 mg (Reference \[R\]) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
|
Griseofulvin 250-T2/Griseofulvin 500-R/Griseofulvin 500-T1
Participants received a single oral dose of Griseofulvin 250 mg (T2) in treatment period 1 (Day 1) followed by Griseofulvin 500 mg (R) in treatment period 2 (Day 8) followed by Griseofulvin 500 mg (T1) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
|
Griseofulvin 500-R/Griseofulvin 500-T1/Griseofulvin 250-T2
Participants received a single oral dose of Griseofulvin 500 mg (R) in treatment period 1 (Day 1) followed by Griseofulvin 500 mg (T1) in treatment period 2 (Day 8) followed by Griseofulvin 250 mg (T2) in treatment period 3 (Day 18). There was a washout period of at least 7 days between 2 subsequent dosing days.
|
|---|---|---|---|
|
Period2washout(Atleast 7 Days Post-dose)
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Bioequivalence (BE) Study of Test Griseofulvin 500 Milligram (mg) Tablets Versus Reference and Dose Proportionality Study of Test Griseofulvin 250 mg and 500 mg Tablets Under Fed Conditions
Baseline characteristics by cohort
| Measure |
All Treated Participants
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1), Griseofulvin 250 mg tablet (T2) and Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|
|
Age, Continuous
|
32.08 Years
STANDARD_DEVIATION 5.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each periodPopulation: Bioequivalence (BE) Analysis Set Population comprised of participants completing at least 2 periods with 500 mg test and 500 mg reference treatments of the study. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized Cmax (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for Cmax to assess bioequivalence.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=35 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) for Griseofulvin
|
2229 Nanograms per milliliter
Standard Error 0.03262
|
2877 Nanograms per milliliter
Standard Error 0.03457
|
1927 Nanograms per milliliter
Standard Error 0.03262
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each periodPopulation: Bioequivalence (BE) Analysis Set Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure AUC(0-t) at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized AUC(0-t) (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for AUC(0-t) to assess bioequivalence.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=35 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin
|
54993 Hours*nanogram per milliliter
Standard Error 0.05305
|
66788 Hours*nanogram per milliliter
Standard Error 0.05560
|
53274 Hours*nanogram per milliliter
Standard Error 0.05305
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each periodPopulation: Bioequivalence (BE) Analysis Set Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were measured using standard non-compartmental methods. For Griseofulvin 250 mg (T2), dose-normalized AUC(0-inf) (observed value multiplied by 2) is reported. Adjusted geometric mean and standard error have been presented for all treatments. Adjusted geometric mean is the antilog (exponential) of the least squares mean of the log-transformed data. Statistical analysis of pharmacokinetic parameters was done using mixed model for evaluation of bioquivalence. Point estimate and 90% confidence interval for the ratio of geometric least square mean of the test Griseofulvin 500 mg (T1) to the reference Griseofulvin 500 mg (R) were calculated for AUC(0-inf) to assess bioequivalence.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=35 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin
|
56746 Hours*nanogram per milliliter
Standard Error 0.05460
|
69564 Hours*nanogram per milliliter
Standard Error 0.05630
|
55100 Hours*nanogram per milliliter
Standard Error 0.05460
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each periodPopulation: Dose Proportionality Analysis Set Population comprised of participants completing at least 2 periods with 500 mg test (T1) and 250 mg test (T2) treatments of the study. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time-points for pharmacokinetic analysis. Pharmacokinetic parameters were measured using standard non-compartmental methods. Dose proportionality was assessed using mixed model. Slope and 90% confidence interval for the slope are presented. For Griseofulvin 250 mg (T2), dose-normalized (observed value multiplied by 2) AUC(0-t) was used during calculation of dose proportionality.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Dose Proportionality of Griseofulvin Using AUC(0-t) Following a Single Dose
|
1.214 Slope of log dose
Interval 1.156 to 1.275
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose (within 1 hour prior to dosing) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 8, 10, 12, 24, 48, 72 and 96 hours post-dose in each periodPopulation: Dose Proportionality Analysis Set Population comprised of participants completing at least 2 periods with 500 mg test (T1) and 250 mg test (T2) treatments of the study. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time-points for pharmacokinetic analysis. Pharmacokinetic parameters were measured using standard non-compartmental methods. Dose proportionality was assessed using mixed model. Slope and 90% confidence interval for the slope are presented. For Griseofulvin 250 mg (T2), dose-normalized (observed value multiplied by 2) Cmax was used during calculation of dose proportionality.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=35 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Dose Proportionality of Griseofulvin Using Cmax Following a Single Dose
|
1.290 Slope of log dose
Interval 1.239 to 1.344
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Analysis Set Population comprised of all randomized participants who received at least one dose of study medication.
An adverse event was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An SAE was any untoward medical occurrence resulting in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, congenital anomaly/birth defect or any other other important medical event that may jeopardize the participant or may require medical or surgical treatment to prevent one of the other outcomes listed before.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE)
Any SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE)
Any non-SAE
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Analysis Set Population
Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse rate, respiration rate and body temperature were measured in semi-supine position after 5 minutes rest. The clinically acceptable range included; SBP: 85 millimeters of mercury (mmHg) to 160 mmHg; DBP: 45 mmHg to 100 mmHg; pulse rate: 40 beats per minute to 110 beats per minute; respiration rate: 8 breaths per minute to 20 breaths per minute; body temperature: 35.5 degrees Celsius to 37.8 degrees Celsius. Number of participants with any abnormality in vital signs are presented.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Any Abnormality in Vital Signs
SBP
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Vital Signs
DBP
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Vital Signs
Pulse rate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Vital Signs
Respiration rate
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Vital Signs
Body temperature
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Analysis Set Population
Blood samples were collected at indicated time points for assessment of hematology parameters. The clinically acceptable range included; hemoglobin: 12.3-18.0 grams per deciliter (g/dL) (for male) and 11.0-16.0 g/dL (for female), erythrocyte count: 4.0-7.1\*10\^12 cells per liter (for male) and 3.6-5.6\*10\^12 cells per liter (for female), hematocrit: 0.41-0.50 proportion of red blood cells in blood (Male) and 0.35-0.44 proportion of red blood cells in blood (Female), Mean Corpuscular Volume (MCV): 80-96 femtoliters, Mean Corpuscular Hemoglobin (MCH): 27.5-33.2 picogram , Mean Corpuscular Hemoglobin Concentration (MCHC): 33.4-35.5 g/dL, White Blood Cell (WBC) count: 3960-12100 cells per microliter, platelet count: 135-495\*10\^9 cells per liter, neutrophils: 36-88%, eosinophils: up to 14%, basophils: 0-2%, lymphocytes: 18-44%, monocytes: 2-10% of total cells. Number of participants with any abnormality in hematology parameters are presented.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Any Abnormality in Hematology Parameters
Hemoglobin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Erythrocyte count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Hematocrit
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
MCV
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
MCH
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
MCHC
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
WBC count
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Neutrophils count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Eosinophils count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Basophils count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Lymphocytes count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Monocytes count
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Hematology Parameters
Platelet count
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Analysis Set Population
Blood samples were collected at indicated time points for assessment of clinical chemistry parameters. The clinically acceptable range included; blood urea: Up to 55 milligrams per deciliter (mg/dL), random blood glucose: 63-140 mg/dL, blood urea nitrogen: Up to 25 mg/dL, serum creatinine: 0.6-1.3 mg/dL (Male) and 0.4-1.0 mg/dL (Female), total serum bilirubin: 0.00-1.47 mg/dL, direct serum bilirubin: 0.0-0.3 mg/dL, indirect serum bilirubin: 0.0-1.5 mg/dL, aspartate aminotransferase (AST): Up to 70 units per liter (U/L) (Male) and Up to 50 U/L (Female). Number of participants with any abnormality in clinical chemistry parameters are presented.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Direct serum bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Total serum bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Blood urea
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Random blood glucose
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Blood urea nitrogen
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Serum creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
Indirect serum bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameters
AST
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days -1, 7, 17 and 22Population: Safety Analysis Set Population
Blood samples were collected at indicated time points for assessment of clinical chemistry parameter. The clinically acceptable range for ALT included; Up to 7270 units per liter (U/L) (Male) and Up to 50 U/L (Female). Number of participants with any abnormality in ALT levels are presented.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT)
Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT)
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT)
Day 17
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT)
Day 22
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days -1, 7, 17 and 22Population: Safety Analysis Set Population. Only those participants with data available at the specified time points were analyzed.
Blood samples were collected at indicated time points for assessment of serum beta-hCG (serum pregnancy test) for female participants. Number of participants with positive results in serum beta-hCG levels are presented.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=5 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=5 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=5 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Positive Results in Serum Beta-human Chorionic Gonadotropin (Beta-hCG) Level (Females Participants)
Day -1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Results in Serum Beta-human Chorionic Gonadotropin (Beta-hCG) Level (Females Participants)
Day 7
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Results in Serum Beta-human Chorionic Gonadotropin (Beta-hCG) Level (Females Participants)
Day 17
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Results in Serum Beta-human Chorionic Gonadotropin (Beta-hCG) Level (Females Participants)
Day 22
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 22Population: Safety Analysis Set Population
Urine samples were collected to assess glucose, ketones, occult blood, protein, urobilinogen and bilirubin by dipstick method. The dipstick test gave results in a semi-quantitative manner, and results can be read as Negative, Trace, 1+, 2+ indicating proportional concentrations in the urine sample. Clinically acceptable range included 'negative' and 'trace' results. Number of participants with any abnormal urinalysis parameters are presented.
Outcome measures
| Measure |
Griseofulvin 500 mg (T1)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 Participants
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 Participants
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Number of Participants With Abnormal Urinalysis Dipstick Results
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Griseofulvin 500 mg (T1)
Griseofulvin 250 mg (T2)
Griseofulvin 500 mg (R)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Griseofulvin 500 mg (T1)
n=36 participants at risk
All participants received a single oral dose of Griseofulvin 500 mg tablet (T1) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 250 mg (T2)
n=36 participants at risk
All participants received a single oral dose of Griseofulvin 250 mg tablet (T2) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
Griseofulvin 500 mg (R)
n=36 participants at risk
All participants received a single oral dose of Griseofulvin 500 mg tablet (R) in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|---|---|
|
Investigations
White blood cell count decreased
|
0.00%
0/36 • Non-SAEs and SAEs were reported from start of study treatment (Day 1) up to Day 22
Non-SAEs and SAEs were reported for Safety Analysis Set Population. Adverse events were presented treatment-wise.
|
0.00%
0/36 • Non-SAEs and SAEs were reported from start of study treatment (Day 1) up to Day 22
Non-SAEs and SAEs were reported for Safety Analysis Set Population. Adverse events were presented treatment-wise.
|
2.8%
1/36 • Number of events 1 • Non-SAEs and SAEs were reported from start of study treatment (Day 1) up to Day 22
Non-SAEs and SAEs were reported for Safety Analysis Set Population. Adverse events were presented treatment-wise.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER