Study: NCT02755064

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythromycin lactobionate
Description: In Phase 1 of the study, during the second visit, erythromycin was given as an initial bolus of 0.5 mg/kg over 10 min immediately before the meal. Thereafter, an infusion of 1.5 or 2.5 mg/kg was given over the next 50 min with the same infusion pump. The goal of testing 2 different doses was not to assess dose-related effects but to compare glycemic indices against a spectrum of gastric emptying rates.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Erythromycin lactobionate
Description: In Phase 1 of the study, during the second visit, erythromycin was given as an initial bolus of 0.5 mg/kg over 10 min immediately before the meal. Thereafter, an infusion of 1.5 or 2.5 mg/kg was given over the next 50 min with the same infusion pump. The goal of testing 2 different doses was not to assess dose-related effects but to compare glycemic indices against a spectrum of gastric emptying rates.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo IV
Description: In Phase 1 of the study, during the second visit, saline was given as an initial bolus over 10 min immediately before the meal. Thereafter, an infusion of saline was given over the next 50 min with the same infusion pump.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [13C]-Spirulina
Description: The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: [13C]-Spirulina
Description: The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: [13C]-Spirulina
Description: The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: [13C]-Spirulina
Description: The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: [13C]-Spirulina
Description: The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Erythromycin Ethylsuccinate Suspension
Description: In Phase 2 of the study, subjects randomized to this arm will receive Erythromycin Ethylsuccinate Suspension 250 mg tid orally for a total period of 7 days.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo Suspension
Description: In Phase 2 of the study, subjects randomized to this arm will receive an oral placebo prepared to mimic the Erythromycin Ethylsuccinate Suspension for a total period of 7 days.