Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Maximum Plasma Concentration (Cmax) for Griseofulvin |
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. |
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 |
|
Primary |
Area Under Plasma Concentration-time Curve (AUC) From Zero Hours to Time of Last Quantifiable Concentration (AUC[0-t]) for Griseofulvin |
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. |
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 |
|
Primary |
AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) for Griseofulvin |
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. |
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 |
|
Primary |
Dose Proportionality of Griseofulvin Using AUC(0-t) Following a Single Dose |
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. |
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 |
|
Primary |
Dose Proportionality of Griseofulvin Using Cmax Following a Single Dose |
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. |
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 |
|
Secondary |
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) |
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. |
Up to Day 22 |
|
Secondary |
Number of Participants With Any Abnormality in Vital Signs |
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. |
Up to Day 22 |
|
Secondary |
Number of Participants With Any Abnormality in Hematology Parameters |
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. |
Up to Day 22 |
|
Secondary |
Number of Participants With Any Abnormality in Clinical Chemistry Parameters |
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. |
Up to Day 22 |
|
Secondary |
Number of Participants With Any Abnormality in Clinical Chemistry Parameter: Alanine Aminotransferase (ALT) |
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. |
Days -1, 7, 17 and 22 |
|
Secondary |
Number of Participants With Positive Results in Serum Beta-human Chorionic Gonadotropin (Beta-hCG) Level (Females Participants) |
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. |
Days -1, 7, 17 and 22 |
|
Secondary |
Number of Participants With Abnormal Urinalysis Dipstick Results |
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. |
Up to Day 22 |
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